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

NCT05218148 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2022-04-06

No results posted yet for this study

Summary

The SOX regimen has became the standard perioperative chemotherapy for locally advanced gastric cancer; The immune checkpoint inhibitors have become a standard treatment for advanced or metastatic gastric cancer；For HER2-positive locally advanced gastric cancer, some phase II studies have shown that chemotherapy combined with trastuzumab can further improve the pathological remission rate;This prospective phase II clinical trial was designed, using SOX combined with sintilimab and trastuzumab to treat HER2 positive locally advanced gastric or gastroesophageal junction adenocarcinoma patients.

Conditions

  • HER2-positive
  • Locally Advanced Solid Tumor
  • Immunotherapy
  • Sintilimab
  • S-1
  • Oxaliplatin
  • Gastric 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.

Sponsors & Collaborators

  • Aiping Zhou

    lead UNKNOWN

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-01
Primary Completion
2024-10-01
Completion
2025-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05218148 on ClinicalTrials.gov