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

Official title

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)

Overview

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.

Interventions

• 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
• 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
• Drug Cisplatin
  80 mg/m²

Primary outcome measures

• Objective remission rate (ORR) [Time frame: 6 months after the last subject participating in]

Secondary outcome measures (5)

• Progression-free survival (PFS) [Time frame: 12 months after the last subject participating in]
• Overall survival (OS) [Time frame: 12 months after the last subject participating in]
• Duration of relief (DOR) [Time frame: 12 months after the last subject participating in]
• Disease control rate (DCR) [Time frame: 6 months after the last subject participating in]
• Safety(adverse event) [Time frame: Up to approximately 2 years]

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;
• History of allogeneic stem cell transplantation or organ transplantation;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 20 centers

• The First Affiliated Hospital of Zhengzhou University — Zhengzhou
• Binzhou Medical University Hospital — Binzhou
• Shengli Oilfield Central Hospital — Dongying
• Shandong Provincial Hospital Affiliated to Shandong First Medical University — Jinan
• Shandong Provincial Third Hospital — Jinan
• Shandong Univerisity Qilu Hospital — Jinan
• Jinan Third People's Hospital — Jinan
• Affiliated Hospital of Jining Medical College — Jining
• … and 12 more centers

Identifiers

NCT: NCT06730373 · RCTS2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗