- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05403242
RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
January 4, 2024 updated by: Dai, Guanghai, Chinese PLA General Hospital
A Multicenter, Open Label,Single Arm,Phase Ib/II Study to Evaluate the Effect and Safety of RC48-ADC Combined With S-1 for First-line Treatment of Advanced Gastroesophageal Adenocarcinoma With Moderate Expression of HER2
This study was a single-arm, open, multi-center Phase Ib/II clinical trial to observe and evaluate the efficacy and safety of RC48-ADC plus S-1 in first-line treatment of advanced gastroesophageal adenocarcinoma with moderate expression of HER2.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
42
Phase
- Phase 2
- Phase 1
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: Ru Jia
- Phone Number: 13811721720
- Email: ashleyjr@163.com
Study Locations
-
-
-
Beijing, China
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Quanli Han
-
Beijing, China
- Recruiting
- Beijing Friendship Hospital
-
Contact:
- Bangwei Cao
-
-
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 and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- At the same time, patients voluntarily participated in the study and signed informed consent;
- Either male or female, aged 18 or older;
- Patients diagnosed by pathological or cytological diagnosis of gastric cancer (GC), gastroesophageal junction carcinoma (GEJ) or esophageal adenocarcinoma had evidence of local advanced lesions or metastases that could not be surgically resected, and were mostly adenocarcinoma confirmed by histological examination;
- No previous systemic therapy; Or had received neoadjuvant/adjuvant chemotherapy but experienced disease progression or recurrence 6 months after the end of treatment;
- HER2 IHC 2+ and FISH-;
- ECOG scores 0-1;
- Estimated survival ≥3 months;
- Women of reproductive age had to undergo a pregnancy test (serum or urine) which was negative within 7 days of enrollment, and volunteer to use an appropriate method of contraception during the observation period and for 12 weeks after the last study drug was given. For men, surgical sterilization or consent to use appropriate methods of contraception during the observation period and for 12 weeks after the last administration of the study drug;
- Patients who comply are expected to be able to follow up on therapeutic outcomes and adverse reactions as required by the regimen.
Exclusion Criteria:
- Five years before first use of the study drug has been diagnosed as other malignant tumor, the effective treatment of basal cell carcinoma, squamous cell carcinoma of the skin and/or the effective removal of cervical cancer in situ and/or except breast cancer;
- Known hypersensitivity to RC48-ADC;
- HBV DNA>500 IU/ mL (or 2000 copies /ml), HCV RNA>103 copies /ml, HBsAg+ and anti-HCV antibody positive;
- History of HIV infection;
- History of receiving any anti-cancer drug/biologic treatment within 4 weeks prior to trial treatment;
- Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RC48-ADC Combined With S-1
|
2.0 mg/kg, IV, d1, every 2 weeks; or 2.5 mg/kg, IV, d1, every 2 weeks
40-60 mg, bid po, d1-10, every 2 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
dose-limiting toxity
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
|
ORR(Objective Response Rate)
Time Frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
|
The proportion of patients whose tumors shrink by a certain amount and remain so for a certain amount of time, including CR+PR cases.
|
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PFS(progression-free survival)
Time Frame: Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year
|
Time from randomness to the first occurrence of disease progression or death from any cause.
|
Imaging tests were performed every 8 weeks (±7 days) from the first year of treatment to assess efficacy, and every 7 weeks (±7 days) after 1 year
|
DOR(Duration of Response )
Time Frame: Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
|
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
|
Imaging tests were performed every 6 weeks (±7 days) from the first year of treatment to assess efficacy, and every 8 weeks (±7 days) after 1 year
|
OS(Overall Survival)
Time Frame: From date of randomization until the date of death from any cause, assessed up to 24 months
|
Time from randomization to death from any cause
|
From date of randomization until the date of death from any cause, assessed up to 24 months
|
AE(Adverse Event)
Time Frame: Up to 2 years
|
The drug safety was assessed by investigator(s) according to NCI-CTCAE v5.0
|
Up to 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
September 20, 2022
Primary Completion (Estimated)
September 1, 2025
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
May 6, 2022
First Submitted That Met QC Criteria
May 30, 2022
First Posted (Actual)
June 3, 2022
Study Record Updates
Last Update Posted (Estimated)
January 8, 2024
Last Update Submitted That Met QC Criteria
January 4, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2022-132-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Advanced Gastroesophageal Adenocarcinoma
-
Astellas Pharma Global Development, Inc.AvailableMetastatic Gastroesophageal Junction (GEJ) Adenocarcinoma | Locally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma Cancer | Metastatic Gastric Adenocarcinoma CancerUnited States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)RecruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditionsUnited States, Puerto Rico
-
Roswell Park Cancer InstituteUnited States Department of DefenseRecruitingClinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastroesophageal Junction Adenocarcinoma | Unresectable Gastroesophageal Junction Adenocarcinoma | Locally Advanced Gastroesophageal Junction... and other conditionsUnited States
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Poland, Spain, Taiwan, United Kingdom
-
Astellas Pharma Global Development, Inc.Active, not recruitingLocally Advanced Unresectable Gastroesophageal Junction (GEJ) Adenocarcinoma or Cancer | Locally Advanced Unresectable Gastric Adenocarcinoma or Cancer | Metastatic Gastric Adenocarcinoma or Cancer | Metastatic Gastroesophageal Junction (GEJ) AdenocarcinomaUnited States, Korea, Republic of, China, Spain, Taiwan, Japan, Argentina, Canada, Croatia, Greece, Ireland, Malaysia, Netherlands, Portugal, Romania, Thailand, Turkey, United Kingdom
-
Ukrainian Society of Clinical OncologyRecruitingStomach Cancer | Gastric Cancer | Gastric Adenocarcinoma | Gastrointestinal Cancer | Gastroesophageal Junction Adenocarcinoma | Advanced Gastric Adenocarcinoma | GastroEsophageal Cancer | Stomach Neoplasm | Gastric Neoplasm | Advanced Gastric Carcinoma | Advanced Gastroesophageal Junction AdenocarcinomaUkraine
-
Roswell Park Cancer InstitutePfizerRecruitingAdvanced Malignant Solid Neoplasm | Metastatic Colorectal Adenocarcinoma | Metastatic Gastroesophageal Junction Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Clinical Stage III... and other conditionsUnited States
-
National Cancer Institute (NCI)Not yet recruitingLocally Advanced Malignant Solid Neoplasm | Unresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Clinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage... and other conditions
-
National Cancer Institute (NCI)Not yet recruitingClinical Stage III Gastric Cancer AJCC v8 | Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 | Clinical Stage IV Gastric Cancer AJCC v8 | Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 | Metastatic Gastric Adenocarcinoma | Metastatic Gastroesophageal Junction... and other conditions
-
Wuhan Union Hospital, ChinaRecruitingAdvanced Gastric Cancer | Advanced Gastroesophageal Junction AdenocarcinomaChina
Clinical Trials on RC48-ADC
-
Cancer Institute and Hospital, Chinese Academy...RecruitingMetastatic Breast CancerChina
-
RemeGen Co., Ltd.Completed
-
RemeGen Co., Ltd.Completed
-
Tianjin Medical University Cancer Institute and...Chongqing University Cancer Hospital; Xiangya Hospital of Central South University and other collaboratorsNot yet recruitingNeoadjuvant Treatment of Her2-positive Muscle-invasive Bladder Cance
-
RemeGen Co., Ltd.RecruitingMuscle Invasive Bladder CarcinomaChina
-
Peking Union Medical College HospitalRecruitingSalivary Gland TumorsChina
-
RemeGen Co., Ltd.Completed
-
RemeGen Co., Ltd.Not yet recruitingNon-small Cell Lung CancerChina