Clinical Trials/NCT06730373

NCT06730373

Recruiting

Phase 2

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)

Qilu Hospital of Shandong University20 sites in 1 country110 target enrollmentOctober 17, 2024

ConditionsHER2-positive Gastric Cancer Metastatic Gastric Cancer Unresectable Gastric Carcinoma

InterventionsS-1 Sintilimab Disitamab Vedotin Trastuzumab Oxaliplatin Capecitabine 5-FU Cisplatin

DrugsDisitamab Vedotin Sintilimab S-1 Trastuzumab Oxaliplatin Capecitabine 5-FU Cisplatin

Overview

Phase: Phase 2
Intervention: S-1
Conditions: HER2-positive Gastric Cancer
Sponsor: Qilu Hospital of Shandong University
Enrollment: 110
Locations: 20
Primary Endpoint: Objective remission rate (ORR)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 17, 2024

End Date

December 31, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Principal Investigator

Lian Liu, MD, PHD

Director

Qilu Hospital of Shandong University

Eligibility Criteria

Inclusion Criteria

•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;

Exclusion Criteria

•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;

Arms & Interventions

Disitamab Vedotin+Sintilimab+S-1

Intervention: S-1

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

Intervention: Sintilimab

Disitamab Vedotin+Sintilimab+S-1

Intervention: Disitamab Vedotin

Disitamab Vedotin+Sintilimab+S-1

Intervention: Sintilimab

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

Intervention: Trastuzumab

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

Intervention: Oxaliplatin

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

Intervention: Capecitabine

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

Intervention: 5-FU

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

Intervention: Cisplatin

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)