SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

October 1, 2024

Study Completion Date

December 1, 2025

Conditions
HER2-positiveLocally Advanced Solid TumorImmunotherapySintilimabS-1OxaliplatinGastric or Gastroesophageal Junction Adenocarcinoma
Interventions
DRUG

sintilimab

Sintilimab 200mg was administered as a 30-60 min intravenous (IV) infusion every 3 weeks.3 cycles before surgery and 5 cycles after surgery.

DRUG

Trastuzumab

Trastuzumab was 8mg/kg for the first time, and 6mg/kg for the follow-up. 3 cycles before surgery and 5 cycles after surgery.

DRUG

S-1 plus oxaliplatin

"Oxaliplatin 130 mg/m2 was administered IV every 3 weeks. S-1 was given orally twice daily for the first 2 weeks of each 3-week cycle. The S-1 dose was 40 mg for body surface area (BSA) \< 1.25 m2, 50 mg for BSA 1.25 to \<1.5 m2 and 60 mg for BSA ≥1.5 m2.~Body surface area \&lt;1.25m2: Tegio 40mg bid day 1 \~ 14; Body surface area 1.25 \~ \&lt;1.5m2: Tegio 50mg bid day 1 \~ 14; Body surface area ≥1.5m2: Tegio 60mg bid day 1 \~ 14; 3 cycles before surgery and 3 cycles after surgery."

Trial Locations (1)

100021

Cancer Hospital & Institute, Chinese Academy of Medical Sciences, Beijing

All Listed Sponsors
lead

Aiping Zhou

UNKNOWN

NCT05218148 - SOX Combined With Sintilimab and Trastuzumab Versus SOX Regimen in the Perioperative Treatment of HER2-positive Locally Advanced Gastric Adenocarcinoma | Biotech Hunter | Biotech Hunter