- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04152889
A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer
April 16, 2020 updated by: zhaogang, RenJi Hospital
A Study to Evaluate Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR)
To evaluate the efficacy and safety of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR) .
Secondary study objective: To observe and evaluate the overall survival and adverse events of Camrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR).
To evaluate the safety ofCamrelizumab in Combination With Docetaxel +S-1 Sequenced by Camrelizumab+S-1 as Adjuvant Treatment Therapy in Stage III Gastric Cancer (PD-L1 + / MSI-H / EBV +/dMMR).
Objective: To explore the incidence of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.
To explore the correlation of PD-L1 + / MSI-H / EBV + /dMMR in stage III gastric cancer.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gang Zhao
- Phone Number: 0086-021-68383731
- Email: zhaogang74313@aliyun.com
Study Locations
-
-
-
Shanghai, China
- Recruiting
- Ethics Committee of Renji Hospital, School of Medicine, Shanghai Jiaotong University
-
Contact:
- Gang Zhao
- Phone Number: 0086-021-68383731
- Email: zhaogang74313@aliyun.com
-
-
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 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- The patients voluntarily joined the study and signed the informed consent;
- ≥ 18 years old, ≥ 80 years old, both male and female;
- Stage III gastric cancer confirmed by pathology,
- ECoG score: 0-1
- Detection of biomarkers in postoperative gastric cancer samples suggests that: PD-L1 + CPS ≥ 10% / MSI-H + / EBV+/dMMR
- No preoperative anti-tumor treatment for gastric cancer, including chemotherapy and local treatment
- During the study treatment period and within 3 months after the end of the study treatment period, a medically recognized contraceptive measure (such as IUD, contraceptive pill or condom) should be used for the female patients of non-surgical sterilization or childbearing age; the serum or urine HCG test of the female patients of non-surgical sterilization must be negative within 72 hours before the study group; and the hCG test must be non lactation; for the male patients Sex, should be surgical sterilization, or agree to use appropriate methods of contraception during the trial and within 3 months after the last administration of the test drug.
- The baseline blood routine and biochemical indexes of the selected patients should meet the following standards:
A. hemoglobin ≥ 90g / L
B. absolute neutrophil count ≥ 1.5 × 10 ^ 9 / L
C. platelet count ≥ 100 × 10 ^ 9 / L
D. ASTor ALT ≤ 2.5 ULN
E. Alkaline phosphatase (ALP)≤ 2.5×ULN
TSH ≤ 1 ULN (if abnormal, T3 and T4 levels should be examined at the same time, if T3 and T4 levels are normal, they can be included in the group);
Exclusion Criteria:
- Pregnant or lactating women;
- Women of childbearing age were positive in the baseline pregnancy test;
- Distant metastasis was diagnosed by CT /MR/ EUS.
- Received previous anti-tumor treatment, including chemotherapy, radiotherapy or immunotherapy;
- Have other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer);
- Uncontrollable pleural effusion, pericardial effusion or ascites;
- Severe cardiovascular diseases such as symptomatic coronary heart disease, congestive heart failure ≥ level II, uncontrolled arrhythmia and myocardial infarction within 12 months before admission;
- With gastroduodenal obstruction/bleeding, digestive dysfunction or malabsorption syndrome
- Complicated with severe uncontrolled concurrent infection or other serious uncontrolled concomitant diseases, moderate or severe renal injury;
- Allergic reaction to the drugs used in this study;
- Steroid or other systemic immunosuppressive therapy was used 14 days before admission;
- Patients who received study drug treatment within 4 weeks before enrollment (participate in other clinical trials).
- Active autoimmune diseases (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, hypothyroidism and asthma requiring bronchodilator treatment). Subjects with hypothyroidism requiring only hormone replacement therapy and skin diseases without systemic treatment (such as vitiligo, psoriasis or alopecia) can be selected.
- History of primary immunodeficiency.
- Immunosuppressive drugs were used within 4 weeks prior to the first dose of study treatment, excluding local or physiological doses of systemic glucocorticoids (i.e. no more than 10mg / day of prednisone or other glucocorticoids of equivalent dose) by nasal spray, inhalation or other routes, or hormones used to prevent allergy of contrast agents.
- Receive live attenuated vaccine within 4 weeks before the first dose of study treatment or during the study period.
- Active tuberculosis is known.
- We have known the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- HIV antibody positive, active hepatitis B or C (hepatitis B: HBsAg positive and HBV DNA ≥ 10 ⁴ copies / ml; hepatitis C: HCV antibody and HCV-RNA positive, requiring antiviral treatment at the same time);.
- Other factors that may affect the safety or test compliance of the subjects according to the judgment of the researchers. For example, serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, or other family or social factors, etc.
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Camrelizumab+chemotherapy
|
Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks.
Repeated every 21 days.
21 days for a cycle.
Other Names:
Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off.
Rrepeated every 21 days.
21 days for a cycle.
Docetaxel: 40 mg/m^2 solution intravenously for 1 hour in first day every 3 weeks.
Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DFS
Time Frame: 1YEARS
|
disease-free survival
|
1YEARS
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gang Zhao, RenJi Hospital, Shanghai JiaoTong University, School of Medicine Shanghai, Shanghai, China, 200127
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)
April 14, 2020
Primary Completion (ANTICIPATED)
April 1, 2022
Study Completion (ANTICIPATED)
December 1, 2022
Study Registration Dates
First Submitted
November 4, 2019
First Submitted That Met QC Criteria
November 4, 2019
First Posted (ACTUAL)
November 5, 2019
Study Record Updates
Last Update Posted (ACTUAL)
April 20, 2020
Last Update Submitted That Met QC Criteria
April 16, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Stomach Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Docetaxel
Other Study ID Numbers
- ZG IIIS
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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