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Cadonilimab Combination Regimen as First-line Treatment for HER2-expressing GC/GEJ Patients

NCT06650332 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-10-21

No results posted yet for this study

Summary

This trial is An open-label, multicohort, multicenter clinical study aimed at evaluating the efficacy and safety of the cadonilimab combination regimen in the treatment of advanced HER-2 positive gastric/gastroesophageal junction tumors

Conditions

  • Metastatic HER2 Positive Gastroesophageal Junction Cancer

Interventions

DRUG

cadonilimab

Cohort 1:10 mg/kg, iv, Q3W, D1; Cohort 2/3:6 mg/kg, iv, Q2W, D1

DRUG

Trastuzumab

loading dose 8 mg/kg, iv, Q3W, D1; maintenance dose 6 mg/kg, iv, Q3W, D1

DRUG

XELOX

Oxaliplatin: 130 mg/m\\(\^2\\), IV, D1; Capecitabine: 1000 mg/m\\(\^2\\), oral (PO), twice daily, D1-14.

DRUG

Disitamab Vedotin

1.5、2.0、2.5mg/kg，IV，D1，Q2W

DRUG

mFOLFOX6

Oxaliplatin 85 mg/m\\(\^2\\), IV, d1; Leucovorin (folinic acid) 400 mg/m\\(\^2\\), IV, d1; 5-FU 400 mg/m\\(\^2\\), IV, d1, followed by 2400 mg/m\\(\^2\\), continuous intravenous infusion over 46 hours.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Jieer Ying, MD · Zhejiang Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-08-10
Completion
2027-12-30

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 NCT06650332 on ClinicalTrials.gov