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Cadonilimab Plus CapeOX as First-Line Treatment for Advanced GC/GEJC With High TMEscore

NCT06202716 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-03-25

No results posted yet for this study

Summary

This is a single-arm, open-label, multi-center clinical study to evaluate the efficacy and safety of PD-1/CTLA-4 bispecific cadonilimab in combination with oxaliplatin/capecitabine (CapeOX) in the first-line treatment of advanced gastric cancer or gastro-esophageal junction adenocarcinoma with a high tumor microenvironment score (TMEscore). The study plans to enroll 50 patients to receive cadonilimab 100mg/kg, iv, q3w + CapeOX (oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, D1-14, q3w, with 3 weeks as a cycle and a maximum of 8 cycles of treatment. Then the maintenance treatment phase with cadonilimab ± capecitabine is entered, and the specific dosage is the same as the treatment period. Effectiveness is assessed every 9 weeks (±7 days) using RECISIT 1.1 until disease recurrence, metastasis, death, or loss of follow-up. The primary endpoint of this study was PFS, and secondary endpoints were OS, ORR, and safety.

Conditions

Interventions

DRUG

Cadonilimab plus CapeOX chemotherapy

Cadonilimab plus oxaliplatin/capecitabine (CapeOX) chemotherapy as first-line treatment in patients with advanced gastric cancer or gastro-esophageal junction adenocarcinoma: Cadonilimab 10mg/kg, iv, q3w + oxaliplatin 130mg/m2, vd, d1 + capecitabine 1000mg/m2, po, bid, d1-d4, q3w (3 weeks as a cycle, a maximum of 8 cycles of treatment). Then the maintenance treatment phase with tislelizumab + lenvatinib is entered, and the specific dosage is the same as the treatment period.

Sponsors & Collaborators

  • Nanfang Hospital, Southern Medical University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2026-04-30
Completion
2026-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06202716 on ClinicalTrials.gov