PD1 Combined With Chemotherapy for Adjuvant Treatment of Gastric Cancer

March 16, 2023 updated by: Shanghai Junshi Bioscience Co., Ltd.

An International, Multicenter, Randomized, Double-blind, Phase III Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection Combined With Postoperative Adjuvant Chemotherapy Versus Placebo Combined With Postoperative Adjuvant Chemotherapy in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma After Radical Gastrectomy

This international, multicenter, randomized, double-blind phase III study intends to recruit 680 patients who have received radical gastrectomy (R0 resection, D2 or more extended lymphadenectomy) with postoperative pathological stage II or III (AJCC Cancer Staging Manual, 8th Edition) gastric or EGJ adenocarcinoma to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

"This is an international, multicenter, randomized, double-blind phase III study, plans to recruit 680 patients who received radical gastrectomy (R0, D2 or higher lymphadenectomy) with postoperative pathological stage II (T4aN0M0) or III (the 8th Edition American Joint Committee on Cancer [AJCC] Cancer Staging Manual) gastric adenocarcinoma and gastroesophageal junction adenocarcinoma, and the study intends to evaluate the efficacy and safety of JS001 combined with postoperative adjuvant chemotherapy versus placebo combined with postoperative adjuvant chemotherapy.

Patients meeting the inclusion criteria will be 1:1 randomized into JS001-chemotherapy group and placebo-chemotherapy group. The random stratification factors include adjuvant chemotherapeutic regimens (XELOX versus SOX) and tumor anatomical sites (gastric adenocarcinoma versus gastroesophageal junction adenocarcinoma).

The study treatment will be initiated 4-6 weeks after surgery, and the investigator will select XELOX (Oxaliplatin + capecitabine) or SOX (Oxaliplatin + S-1, tegafur, gimeracil and oteracil potassium) as the adjuvant chemotherapeutic regimen given as 3-week cycles for up to 8 cycles based on each patient's condition; JS001/placebo will be given for up to 17 cycles after surgery, until intolerable toxicity, disease recurrence, patient's withdrawal of consent, investigator's judgment that the patient needs to be withdrawn from the study treatment, or death, whichever comes first.

Safety evaluation, including vital signs, ECOG score, physical examination and laboratory examinations, will be performed on a regular basis during the treatment.

This study will end after the main analysis node of DFS and unblinding for analysis are achieved, or 5 years after enrollment of the last patient, whichever comes first. The Sponsor is entitled to terminate the study at any time due to specific reasons (e. g, major safety issues, force majeure, etc.).

Radiological follow-up: tumor response evaluation will be performed once every 12 weeks ±7 days within the first 5 years after randomization, and once per year subsequently, until disease recurrence or death. When symptoms or signs of suspected recurrence/metastasis occur, the radiological evaluation can be performed at any time. Disease recurrence is defined as local recurrence or distant metastases with clear radiological evidence (CT or MRI).

Survival follow-up: it will be performed once every 12 weeks after disease recurrence, until patient's withdrawal of informed consent, loss to follow-up or death, whichever comes first.

Safety follow-up: adverse events will be closely followed up and recorded, until 60 days after the last dose of treatment or the end of study follow-up (death, loss to follow-up, withdrawal of consent form and the end of study), whichever comes first.

"

Study Type

Interventional

Enrollment (Anticipated)

680

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Bengbu, Anhui, China, 233300
        • Recruiting
        • the First Affiliated Hospital of Bengbu Medical College
      • Chizhou, Anhui, China
        • Recruiting
        • The Peple's Hospital of Chizhou
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University People's Hospital
      • Beijing, Beijing, China, 100050
        • Recruiting
        • Beijing Friendship Hospital, Capital Medical University
      • Beijing, Beijing, China, 100005
        • Not yet recruiting
        • Beijing Hospital
      • Beijing, Beijing, China, 100000
        • Recruiting
        • Chinese PLA General Hospital
      • Beijing, Beijing, China, 510515
        • Recruiting
        • Beijing Cancer Hospital
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical Universit
    • Fujian
      • Fuzhou, Fujian, China, 350011
        • Recruiting
        • Fujian Provincial Cancer Hospital
      • Xiamen, Fujian, China, 361003
        • Not yet recruiting
        • The First Affiliated Hospital of Xiamen University
    • Gansu
      • Lanzhou, Gansu, China, 750050
        • Recruiting
        • The First Hospital of Lanzhou University
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Gansu Provincial People's Hospital
      • Lanzhou, Gansu, China, 730000
        • Recruiting
        • Lanzhou University Second Hospital
      • Lanzhou, Gansu, China, 730050
        • Recruiting
        • Gansu Provincial Cancer Hospital
      • Wuwei, Gansu, China, 733000
        • Recruiting
        • Wuwei Cancer Hospital of Gansu Province
    • Guandong
      • Guangzhou, Guandong, China, 510280
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
      • Guangzhou, Guandong, China, 510000
        • Recruiting
        • Guandong General Hospital
    • Guangdong
      • Foshan, Guangdong, China, 528000
        • Recruiting
        • The First People's Hospital of Foshan
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • The First Affiliated Hospital of Sun Yat-sen University
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Nanfang Hospital of Southern Medical University
      • Guangzhou, Guangdong, China, 510095
        • Not yet recruiting
        • Affiliated Cancer Hospital and Institute of Ghuangzhou Medical University
      • Shaoguan, Guangdong, China, 512099
        • Not yet recruiting
        • Yuebei People's Hospital
        • Contact:
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen People's Hospital
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Peking University Shenzhen Hospital
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • Guangxi Medical University Affiliated Tumor Hospital
    • Guizhou
      • Zunyi, Guizhou, China, 563099
        • Recruiting
        • Affiliated Hospital of Zunyi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050011
        • Recruiting
        • The Fourth Hospital of Hebei Medical University
    • Heilongjiang
      • Ha'erbin, Heilongjiang, China, 150086
        • Not yet recruiting
        • The 2ed Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Harbin Medical University Cancer Hospital
    • Henan
      • Luoyang, Henan, China, 450052
        • Not yet recruiting
        • The First Affiliated Hospital of Henan University of Science and Technology
        • Contact:
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Henan Cancer Hospital
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430079
        • Recruiting
        • Hubei Cancer Hospital
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
      • Xiangyang, Hubei, China, 441021
        • Recruiting
        • Xiangyang Central Hospital
        • Contact:
      • Yichang, Hubei, China, 443008
        • Not yet recruiting
        • Yichang Central People's Hospital
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
      • Changsha, Hunan, China, 410031
        • Recruiting
        • Hunan Cancer Hopital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213004
        • Not yet recruiting
        • The First People's Hospital of Changzhou
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Jiangsu Cancer Hospital
      • Nanjing, Jiangsu, China, 210029
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Nantong, Jiangsu, China, 226006
        • Not yet recruiting
        • Nantong Tumor Hospital
        • Contact:
      • Wuxi, Jiangsu, China, 214001
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
      • Nanchang, Jiangxi, China, 330006
        • Not yet recruiting
        • Jiangmen Central Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • The First Hospital of Jilin University
      • Changchun, Jilin, China, 130033
        • Not yet recruiting
        • China-Japan Union Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shengyang, Liaoning, China, 110000
        • Recruiting
        • The First Hospital of China Medical University
      • Shenyang, Liaoning, China, 110000
        • Recruiting
        • Liaoning cancer Hospital & Institute
    • Ningxia
      • Yinchuan, Ningxia, China, 750000
        • Recruiting
        • General Hospital of Ningxia Medical University
    • Qinghai
      • Xining, Qinghai, China, 810000
        • Recruiting
        • Qinghai University Affiliated Hosptial
    • Shandong
      • Jinan, Shandong, China, 250117
        • Not yet recruiting
        • Shandong Cancer Hospital
        • Contact:
      • Linyi, Shandong, China, 276002
        • Not yet recruiting
        • LinYi Cancer Hospital
        • Contact:
      • Qingdao, Shandong, China, 266003
        • Not yet recruiting
        • The Affiliated Hospital Of Qingdao University
        • Contact:
      • Qingdao, Shandong, China, 266042
        • Not yet recruiting
        • Qingdao central medical group
        • Contact:
    • Shangdong
      • Jinan, Shangdong, China, 250012
        • Recruiting
        • Jinan Central Hospital
      • Jinan, Shangdong, China, 250031
        • Recruiting
        • Shandong Provincial Hospital
      • Jining, Shangdong, China, 272007
        • Recruiting
        • Affiliated Hospital of Jining Medical University
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Recruiting
        • Zhongshan Hospital, Fudan University
      • Shanghai, Shanghai, China, 200080
        • Recruiting
        • Shanghai General Hospital
    • Shanxi
      • Taiyuan, Shanxi, China, 030012
        • Recruiting
        • Shanxi Provincial People's Hospital
      • Xian, Shanxi, China, 710000
        • Recruiting
        • Tangdu hospital, Air force Military Medical University
      • Xian, Shanxi, China, 710000
        • Recruiting
        • Xijing hospital, Air force Military Medical University
    • Sichuan
      • Chengdu, Sichuan, China, 610000
        • Recruiting
        • Sichuan Cancer Hospital
      • Suining, Sichuan, China, 629000
        • Recruiting
        • Suining Central Hospital
    • Xinjiang
      • Urumqi, Xinjiang, China, 830000
        • Recruiting
        • Cancer Hospital affiliated to Xinjiang Medical University
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Recruiting
        • The second affiliated hospital of zhejiang university school of medicine
      • Hangzhou, Zhejiang, China
        • Recruiting
        • The first affiliated hospital of Zhejiang medical university
      • Jiaxing, Zhejiang, China, 314001
        • Not yet recruiting
        • The First hospital of Jiaxing
        • Contact:
      • Wenzhou, Zhejiang, China, 325024
        • Recruiting
        • The Second Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

INCLUSION CRITERIA

  1. Age 18-75 years.
  2. No residual tumor (R0) after D2 or greater lymphadenectomy through laparotomy.
  3. According to the definition of the 8th edition of the AJCC Cancer Staging Manual, patients with gastric adenocarcinoma confirmed by histopathology, pathological stage II (T4aN0M0) and stage III, including gastroesophageal junction adenocarcinoma (GEJ) patients.
  4. ECOG performance status 0-1.
  5. No metastasis or recurrence as radiologically confirmed.
  6. Patients must have adequate organ function as assessed in the laboratory tests.
  7. Patients must provide informed consent for this study, and sign the written informed consent form voluntarily before the initiation of the study, and are willing and able to comply with the scheduled visits, treatment plan, laboratory examinations and other study procedures in the study.
  8. Female patients of childbearing age must take a serum pregnancy test within 7 days before randomization with negative results, and agree to adopt reliable and effective contraceptive methods during the study.

4.2 EXCLUSION CRITERIA

  1. Previous use of non-surgical therapy for gastric adenocarcinoma.
  2. Having liver, peritoneal or distant metastasis.
  3. Inability to take the drug orally.
  4. Having postoperative complications that are not relieved at the time of randomization.
  5. Uncontrolled pericardial effusion or pleural effusion which required invasive treatment, and grade II or above peritoneal effusion (diagnosed clinically) present at screening.
  6. Presence of contraindicated chemotherapeutic drugs in this study and failure to receive the adjuvant therapeutic regimen in any group specified in the protocol.
  7. Having received any surgery not for gastric adenocarcinoma requiring general anesthesia within 28 days prior to randomization.
  8. Having malignant tumors other than gastric adenocarcinoma within 5 years before randomization.
  9. Active autoimmune disorders requiring systemic treatment.
  10. Patients with immunodeficiency or receiving long-term systemic steroid therapy.
  11. Concurrent diverticulitis or symptomatic gastrointestinal ulcer disease.
  12. Patients who are receiving or requiring anticoagulant therapy.
  13. Patients with serious cardiovascular and cerebrovascular diseases.
  14. Diabetes mellitus that is not effectively controlled.
  15. Active infections requiring treatment.
  16. ≥Grade 2 peripheral neuropathy.
  17. Patients with active tuberculosis or having received anti-tuberculosis therapy within one year prior to randomization.
  18. Patients currently having interstitial lung disease or having a history of interstitial lung disease.
  19. Hepatitis B, known positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb), and HBV DNA≥1000cps/ml; hepatitis C, positive HCV RNA or RNA ≥1000cps/ml.
  20. Human immunodeficiency virus (HIV) antibody positive.
  21. Vaccination of any live vaccine within 4 weeks before randomization.
  22. Previous allogeneic bone marrow transplantation or solid organ transplantation.
  23. Previous treatment targeting PD-1 receptor or its ligand PD-L1 or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) receptor;
  24. Previous history of serious allergy to monoclonal antibody or other biological preparations.
  25. Having participated in other interventional clinical studies within 28 weeks before randomization.
  26. Having clinically significant underlying medical disease that may affect administration of study drug or compliance to the protocol, as judged by investigators.
  27. Other patients who are considered by investigators as inappropriate for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: JS001 240mg, Q3W with XELOX regimen or SOX regimen

JS001 240mg, will be intravenously administered once every 3 weeks, until 17 cycles XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W.

SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Biological: JS001/Placebo
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
Other Names:
  • Postoperative Adjuvant Chemotherapy
Placebo Comparator: Placebo combine with chemotherapy

XELOX regimen (oxaliplatin + capecitabine) or SOX regimen (oxaliplatin + S-1), given in one therapeutic cycle of 3 weeks for up to 8 cycles XELOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; capecitabine, 1000mg/m2, orally, twice per day, from day 1 to day 14, Q3W.

SOX regimen: Oxaliplatin, 130mg/m2, intravenous drip for over 3 hours, day 1, Q3W; S-1 Capsules, 40-60mg, orally, twice per day, from day 1 to day 14, Q3W.
Biological: JS001/placebo combine with Postoperative Adjuvant Chemotherapy
JS001/placebo combine with Postoperative Adjuvant Chemotherapy
Other Names:
  • Postoperative Adjuvant Chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS evaluated by the BICR based on RECIST v1.1
Time Frame: Through study completion, average of 60 months
To evaluate the disease-free survival (DFS) as per RECIST v1.1 by the blind independent central review (BICR) for toripalimab injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or EGJ adenocarcinoma after radical gastrectomy.
Through study completion, average of 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS evaluated by the investigator based on RECIST v1.1
Time Frame: Through study completion, average of 60 months
To evaluate the disease-free survival (DFS) evaluated by the investigator for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
Through study completion, average of 60 months
DFS rate at 3 years evaluated by the BICR based on RECIST v1.1
Time Frame: 36 months
To evaluate the postoperative DFS rate and overall survival (OS) rate at 3 years for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
36 months
DFS rate at 5 years evaluated by the BICR based on RECIST v1.1
Time Frame: 60 months
To evaluate the postoperative DFS rate and overall survival (OS) rate at 5 years for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
60 months
OS
Time Frame: 5 years
To evaluate the OS for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
5 years
Overall survival rate (OS rate) at 3 years and 5 years
Time Frame: 3 years and 5 years
To evaluate the postoperative overall survival (OS) rate at 3 for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
3 years and 5 years
Time to local recurrence (TTLR)
Time Frame: Through study completion, average of 60 months
To evaluate the time to local recurrence (TTLR) for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
Through study completion, average of 60 months
Time to response (TTR)
Time Frame: Through study completion, average of 60 months
To evaluate thetime to recurrence (TTR) for Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
Through study completion, average of 60 months
Incidence and severity of adverse events (AE),clinically significant abnormal changes in vital signs, ECOG scores, physical examination, electrocardiogram (ECG), echocardiography and laboratory examinations
Time Frame: Through study completion, average of 60 months
To evaluate the safety of Toripalimab Injection (JS001) combined with adjuvant chemotherapy versus placebo combined with adjuvant chemotherapy in patients with gastric or gastroesophageal junction adenocarcinoma after radical gastrectomy.
Through study completion, average of 60 months
To explore the correlation of PD-L1 status, tumor mutation burden (TMB) status, microsatellite status and EBV status with DFS, DFS rate , OS, OS rate at ,TTLR and TTR[efficacy] of adjuvant therapy.
Time Frame: Within 6 Months after C1D1
To evaluate the correlation of PD-L1 status, tumor mutation burden (TMB) status, microsatellite status and EBV status with the efficacy of adjuvant therapy.
Within 6 Months after C1D1
To evaluate the potential correlation of the incidence of ADA of Toripalimab Injection (JS001) with incidence and severity of adverse events (AE)[safety] and DFS, DFS rate , OS, OS rate ,TTLR and TTR[efficacy].
Time Frame: At every other cycle（each cycle is 21 days）up to 17 cycles
To evaluate the incidence and titer of anti-drug antibody (ADA) of Toripalimab Injection (JS001).
At every other cycle（each cycle is 21 days）up to 17 cycles
To evaluate the quality of life in the two groups using the EORTC QLQ-C30 questionnaires
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately years
To evaluate the disease-related symptoms and health-related quality of life (HRQoL) in the two groups through the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life questionnaire (EORTC QLQ-C30) a. The EORTC QLQ-C30 consists of three subscales with 30 questions. The EORTC QLQ-C30 have three subscales in the scale include functioning scales (15 questions), symptom scales (13 questions), and global health status (2 questions). The reliability and validity of Cronbach'α was 0.81-0.94. The functional scale and the global health status , the higher the total score, the better the quality of life; the lower the score in the symptom scale, the better the quality of life.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately years
To evaluate the quality of life in the two groups using the EORTC QLQ-STO22 questionnaires
Time Frame: From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately years
To evaluate the disease-related symptoms and health-related quality of life (HRQoL) in the two groups through the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Stomach (QLQ-STO22).The EORTC QLQ-STO22 consists of one subscale with 22 questions.The EORTC QLQ-STO22 scale include symptom scales (22 questions) The Cronbach'α was 0.70-0.94.The lower the score in the symptom scale, the better the quality of life.
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to 1 approximately years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Junshi Bioscience Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2022

Primary Completion (Anticipated)

March 31, 2026

Study Completion (Anticipated)

July 31, 2028

Study Registration Dates

First Submitted

November 8, 2021

First Submitted That Met QC Criteria

January 4, 2022

First Posted (Actual)

January 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 20, 2023

Last Update Submitted That Met QC Criteria

March 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS001-045-III-GC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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