TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.
NCT07602140 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-05-22
Summary
This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.
Conditions
- Gastric Cancer With Liver Metastases
Interventions
- OTHER
-
TACE combined with thermal ablation
The decision to perform transarterial chemoembolization (TACE) and/or thermal ablation is based on the blood supply, size, and number of liver metastases as determined by imaging examinations. Interventional therapy is repeated every two cycles, and TACE and/or thermal ablation therapy are selected based on the blood supply, location, size and number of liver metastases.
- DRUG
-
Targeted Therapy
Disitamab Vedotin For Injection: 2.5 mg/kg, day 1, IV drip , Q3W.
- DRUG
-
Immunotherapy
Sintilimab : 200mg , d1 , ivdrip , q3w
- DRUG
-
S-1 : 40-60 mg/dose, orally, twice daily (bid), daily (days 1-14) , every 3 weeks (q3w).
Sponsors & Collaborators
-
Shandong Provincial Hospital
lead OTHER_GOV
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-08-01
- Primary Completion
- 2028-08-01
- Completion
- 2029-08-01
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