First-line Treatment With RC48 Plus Sintilimab and S-1 in Advanced Gastric Cancer (RCTS2)

December 29, 2024 updated by: Lian Liu, MD, PHD, Qilu Hospital of Shandong University

A Phase II, Open-Label, Multicenter Trial Comparing Disitamab Vedotin Plus Sintilimab and S-1 With Trastuzumab Plus Chemotherapy ± Sintilimab for First-Line Treatment of HER2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (RCTS2)

This is a Phase II, randomized, multicenter, open-label clinical trial designed to compare Disitamab Vedotin plus Sintilimab and S-1 with Trastuzumab plus chemotherapy ± Sintilimab for first-line treatment of HER2-Positive advanced gastric or gastroesophageal junction adenocarcinoma.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

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: Lian Liu, MD
  • Phone Number: 0531-82169851
  • Email: tounao@126.com

Study Contact Backup

  • Name: Song Li, MD
  • Phone Number: 0531-82169851

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
        • Contact:
    • Shandong
      • Binzhou, Shandong, China
        • Not yet recruiting
        • Binzhou Medical University Hospital
        • Contact:
          • Feng Wang
      • Dongying, Shandong, China
        • Recruiting
        • Shengli Oilfield Central Hospital
        • Contact:
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong First Medical University
        • Contact:
        • Principal Investigator:
          • Lei Cong, MD
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Provincial Third Hospital
        • Contact:
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Shandong Univerisity Qilu Hospital
        • Contact:
      • Jinan, Shandong, China
        • Recruiting
        • Jinan Third People's Hospital
        • Contact:
          • Zupeng Luan
      • Jining, Shandong, China
        • Recruiting
        • Affiliated Hospital of Jining Medical College
        • Contact:
          • Junye Wang, MD
      • Liaocheng, Shandong, China
        • Recruiting
        • Liaocheng People's Hospital
        • Contact:
          • Baozhong Wang
      • Linyi, Shandong, China
        • Recruiting
        • Linyi Cancer Hospital
        • Contact:
          • Zhen Li
      • Qingdao, Shandong, China
        • Not yet recruiting
        • The Affiliated Hospital of Qingdao University
        • Contact:
          • Zimin Liu
      • Qingdao, Shandong, China, 250063
        • Recruiting
        • Qilu Hospital of Shandong University(Qingdao)
        • Contact:
      • Taian, Shandong, China
        • Recruiting
        • The Second Affiliated Hospital of Shandong First Medical University
        • Contact:
      • Taian, Shandong, China
        • Not yet recruiting
        • Taian City Central Hospital
        • Contact:
          • Li Meng, MD
      • Tengzhou, Shandong, China, 277599
        • Recruiting
        • Tengzhou Central People's Hospital
        • Contact:
      • Weifang, Shandong, China
        • Not yet recruiting
        • Weifang Hospital of Traditional Chinese Medicine
        • Contact:
          • Zhonghai Du
      • Yantai, Shandong, China
      • Yantai, Shandong, China
        • Recruiting
        • Yantaishan Hospital
        • Contact:
      • Zibo, Shandong, China
        • Recruiting
        • Zibo Central Hospital
        • Contact:
      • Zibo, Shandong, China
        • Recruiting
        • Zibo First People's Hospital
        • Contact:
          • Fei Ding

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged18-75 years, gender is not limited;
  2. Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
  3. HER2-Positive (IHC3+or IHC2+/FISH+) ;
  4. Has at least 1 measurable lesion as determined by RECIST 1.1;
  5. There is no systematic treatment in the past, or the patient has received neoadjuvant/adjuvant chemotherapy, but the disease progresses or relapses more than 6 months after the end of treatment;
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
  7. Adequate organ function;
  8. The life expectancy is at least 3 months;

Exclusion Criteria:

  1. Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
  2. Cardiovascular and cerebrovascular events that are not well controlled;
  3. Has received systematic treatment with Chinese patent medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, except for local use for ascites control) before the first administration within 2 weeks.
  4. Have a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, acute lung disease, or systemic disease with poor control (including but not limited to diabetes, hypertension, etc.);
  5. Have a history of active immune deficiency or autoimmune diseases, including HIV positive test, or have other acquired or congenital immune deficiency diseases, or have a history of organ transplantation or autoimmune diseases;
  6. Severe chronic or active infection requires systemic antibacterial, antifungal or antiviral treatment, including tuberculosis infection.Have a history of active tuberculosis infection ≥ 1 year before recruitment should also be excluded, unless proved has been completed appropriate treatment;
  7. Brain metastasis or leptomeningeal metastasis;
  8. Clinically significant pleural effusion, pericardial effusion or ascites should be drained for many times within 2 weeks before the first administration of the trial drug;
  9. Has a second clinically detectable primary malignant tumor at the time of recruitment, or there were other malignant tumors in the past 5 years (except for fully treated skin basal cell carcinoma or cervical carcinoma in situ);
  10. Any major surgery was performed ≤ 28 days before the first trial drug administration;
  11. History of allogeneic stem cell transplantation or organ transplantation;

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Disitamab Vedotin+Sintilimab+S-1
Drug: Disitamab Vedotin
2.5 mg/kg IV every 3 weeks
Drug: Sintilimab
200 mg IV every 3 weeks
Drug: S-1
40-60 mg BID for 14 days, every 3 weeks
Active Comparator: Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab
Drug: Cisplatin
80 mg/m²
Drug: Sintilimab
200 mg IV every 3 weeks
Drug: Trastuzumab
First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks
Drug: Oxaliplatin
130 mg/m2 Q3W
Drug: Capecitabine
1000 mg/m² Q3W
Drug: 5-FU
800 mg/m²

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective remission rate (ORR)
Time Frame: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) in total subjects
6 months after the last subject participating in

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety(adverse event)
Time Frame: Up to approximately 2 years
to evaluate safety including adverse event rate and adverse event grade.
Up to approximately 2 years
Progression-free survival (PFS)
Time Frame: 12 months after the last subject participating in
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
12 months after the last subject participating in
Overall survival (OS)
Time Frame: 12 months after the last subject participating in
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
12 months after the last subject participating in
Duration of relief (DOR)
Time Frame: 12 months after the last subject participating in
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
12 months after the last subject participating in
Disease control rate (DCR)
Time Frame: 6 months after the last subject participating in
The proportion of subjects with complete response (CR) and partial response (PR) and stable disease(SD)in total subjects
6 months after the last subject participating in

Collaborators and Investigators

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

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Chair: Lian Liu, MD, Qilu Hospital of Shandong University

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)

October 17, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 4, 2024

First Submitted That Met QC Criteria

December 8, 2024

First Posted (Actual)

December 12, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 29, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCTS2

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

product manufactured in and exported from the U.S.

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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