RecruitingPhase 2NCT06730373

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

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)


Sponsor

Qilu Hospital of Shandong University

Enrollment

110 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three treatments — RC48 (a targeted antibody-drug), sintilimab (an immunotherapy), and S-1 (a chemotherapy pill) — as a first treatment option for people with advanced stomach or esophageal junction cancer. **You may be eligible if...** - You are 18–75 years old - You have been diagnosed with advanced or metastatic stomach or gastroesophageal junction cancer that cannot be surgically removed - Your tumor tests HER2-positive - You have not received prior systemic treatment, or you received chemotherapy that finished more than 6 months ago and the cancer has returned - You are in generally good functional condition (able to carry out light activity) - Your organs (liver, kidneys, blood) are functioning adequately - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You have brain metastases or cancer that has spread to the lining of the brain - You have a history of autoimmune disease, organ transplant, or HIV - You have active severe infections (including tuberculosis) - You have uncontrolled lung disease, heart disease, or poorly managed chronic conditions - You have had major surgery in the past 28 days - You have another active cancer Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDisitamab Vedotin

2.5 mg/kg IV every 3 weeks

DRUGSintilimab

200 mg IV every 3 weeks

DRUGS-1

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

DRUGTrastuzumab

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

DRUGOxaliplatin

130 mg/m2 Q3W

DRUGCapecitabine

1000 mg/m² Q3W

DRUG5-FU

800 mg/m²

DRUGCisplatin

80 mg/m²


Locations(20)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Binzhou Medical University Hospital

Binzhou, Shandong, China

Shengli Oilfield Central Hospital

Dongying, Shandong, China

Shandong Provincial Hospital Affiliated to Shandong First Medical University

Jinan, Shandong, China

Shandong Provincial Third Hospital

Jinan, Shandong, China

Shandong Univerisity Qilu Hospital

Jinan, Shandong, China

Jinan Third People's Hospital

Jinan, Shandong, China

Affiliated Hospital of Jining Medical College

Jining, Shandong, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Qilu Hospital of Shandong University(Qingdao)

Qingdao, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Taian City Central Hospital

Taian, Shandong, China

The Second Affiliated Hospital of Shandong First Medical University

Taian, Shandong, China

Tengzhou Central People's Hospital

Tengzhou, Shandong, China

Weifang Hospital of Traditional Chinese Medicine

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Yantaishan Hospital

Yantai, Shandong, China

Zibo Central Hospital

Zibo, Shandong, China

Zibo First People's Hospital

Zibo, Shandong, China

View Full Details on ClinicalTrials.gov

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NCT06730373


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