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

NCT06730373 | Recruiting Phase 2

• 1 other identifier: RCTS2
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 20

Brief Summary

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.

Conditions

HER2-positive Gastric Cancer; Metastatic Gastric Cancer; Unresectable Gastric Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective remission rate (ORR)

  The proportion of subjects with complete response (CR) and partial response (PR) in total subjects

  6 months after the last subject participating in

Secondary Outcomes (5)

• Progression-free survival (PFS)

  12 months after the last subject participating in

• Overall survival (OS)

  12 months after the last subject participating in

• Duration of relief (DOR)

  12 months after the last subject participating in

• Disease control rate (DCR)

  6 months after the last subject participating in

• Safety(adverse event)

  Up to approximately 2 years

Study Arms (2)

Disitamab Vedotin+Sintilimab+S-1

EXPERIMENTAL

Drug: Disitamab Vedotin; Drug: Sintilimab; Drug: S-1

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

ACTIVE COMPARATOR

Drug: Sintilimab; Drug: Trastuzumab; Drug: Oxaliplatin; Drug: Capecitabine; Drug: 5-FU; Drug: Cisplatin

Interventions

Disitamab Vedotin DRUG

2.5 mg/kg IV every 3 weeks

Disitamab Vedotin+Sintilimab+S-1

Sintilimab DRUG

200 mg IV every 3 weeks

Disitamab Vedotin+Sintilimab+S-1; Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

S-1 DRUG

40-60 mg BID for 14 days, every 3 weeks

Disitamab Vedotin+Sintilimab+S-1

Trastuzumab DRUG

First load dose is 8.0mg/kg , then 6.0 mg/kg IV every 3 weeks

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

Oxaliplatin DRUG

130 mg/m2 Q3W

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

Capecitabine DRUG

1000 mg/m² Q3W

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

5-FU DRUG

800 mg/m²

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

Cisplatin DRUG

80 mg/m²

Trastuzumab+Chemotherapy（XELOX/FP/XP) ± Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged18-75 years, gender is not limited;
• Pathologically confirmed locally advanced gastric or gastroesophageal junction adenocarcinoma that is inoperable or has distant metastasis;
• HER2-Positive (IHC3+or IHC2+/FISH+) ;
• Has at least 1 measurable lesion as determined by RECIST 1.1;
• 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;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
• Adequate organ function;
• The life expectancy is at least 3 months;

You may not qualify if:

• Allergy to any trial drug and its excipients, or serious allergy history, or contraindication of the trial drug;
• Cardiovascular and cerebrovascular events that are not well controlled;
• 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.
• 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.);
• 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;
• 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;
• Brain metastasis or leptomeningeal metastasis;
• 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;
• 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);
• Any major surgery was performed ≤ 28 days before the first trial drug administration;
• History of allogeneic stem cell transplantation or organ transplantation;

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (20)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Binzhou Medical University Hospital

Binzhou, Shandong, China

NOT YET RECRUITING

Shengli Oilfield Central Hospital

Dongying, Shandong, China

RECRUITING

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, 250012, China

RECRUITING

Shandong Provincial Third Hospital

Jinan, Shandong, 250012, China

RECRUITING

Shandong Univerisity Qilu Hospital

Jinan, Shandong, 250012, China

RECRUITING

Jinan Third People's Hospital

Jinan, Shandong, China

RECRUITING

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

RECRUITING

Liaocheng People's Hospital

Liaocheng, Shandong, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

RECRUITING

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, 250063, China

RECRUITING

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

NOT YET RECRUITING

Taian City Central Hospital

Taian, Shandong, China

NOT YET RECRUITING

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

RECRUITING

Tengzhou Central People's Hospital

Tengzhou, Shandong, 277599, China

RECRUITING

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, China

NOT YET RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, China

RECRUITING

Yantaishan Hospital

Yantai, Shandong, China

RECRUITING

Zibo Central Hospital

Zibo, Shandong, China

RECRUITING

Zibo First People's Hospital

Zibo, Shandong, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

disitamab vedotin; sintilimab; S 1 (combination); Trastuzumab; Oxaliplatin; Capecitabine; Fluorouracil; Cisplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Lian Liu, MD

  Qilu Hospital of Shandong University

  STUDY CHAIR

Central Study Contacts

Lian Liu, MD

CONTACT

0531-82169851; tounao@126.com

Song Li, MD

CONTACT

0531-82169851

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 12, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 31, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)