Carrelizumab (PD-1) Combined With Chemotherapy in Neoadjuvant Treatment of Locally Advanced Gastric Cancer

Sponsor
Third Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT05545436
Phase
PHASE2
Status
Unknown

Conditions

  • Locally Advanced Gastric Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) — DRUG
    Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine ) Drug: Camrelizumab 200mg Drug: oxaliplatin 130 mg/m2 Drug: Teggio 40 mg/m2 Drug: oxaliplatin 130 mg/m2 Drug: capecitabine 1000 mg/m2 Q3W for 3 cycles. Radical surgery was performed 3 weeks after the last neoadjuvant treatment.

Study Details

This is a single-arm, open, exploratory clinical study to evaluate the efficacy of carrelizumab (PD-1) combined with chemotherapy (SOX/XELOX) as neoadjuvant therapy and to observe the changes of tumor immune microenvironment in patients with locally advanced gastric or gastroesophageal junction cancer (T3-4NXM0).

Key Dates

Start date
Sep 20, 2022
Status verified
Sep 2022
Primary completion
Dec 31, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
34 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Camrelizumab + SOX (oxaliplatin + Teggio) /XELOX (oxaliplatin + capecitabine )
    Camrelizumab + SOX / XELOX

Primary Outcome Measure

Pathological complete response rate (pCR, Becker criteria, TRG 1A) [ Time Frame: Up to approximately 6 months. ]

Central Contacts