Health Trials

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.

ConditionGastric Cancer With Liver Metastases
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShandong Provincial Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.

Male or female, aged 18 or older and 75 or younger;

ECOG score is 0-1;

Expected survival time ≥ 3 months;

Disqualifiers

diagnosed with other malignant tumors within 5 years prior to the first dose and who are not cured (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and/or carcinoma in situ that has been radically removed);

Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose;

Previous treatment with the following: antibody-drug conjugates, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);

Within 28 days prior to the first administration of the study drug, the target lesion had received local treatment (including transarterial chemoembolization/TACE, hepatic artery infusion chemotherapy/TAC, radiotherapy, radioembolization or ablation, etc.);

Trial design

Design model

Single group

Treatments tested in this trial

  • TACE combined with thermal ablation

    Other intervention

    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.

  • Targeted Therapy

    Drug

    Disitamab Vedotin For Injection: 2.5 mg/kg, day 1, IV drip , Q3W.

  • Immunotherapy

    Drug

    Sintilimab : 200mg , d1 , ivdrip , q3w

  • Chemotherapy

    Drug

    S-1 : 40-60 mg/dose, orally, twice daily (bid), daily (days 1-14) , every 3 weeks (q3w).

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Interventional therapy + Chemotherapy + Targeted Therapy + ImmunotherapyExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective response rate (ORR)

The proportion of subjects who achieve complete response (CR) and partial response (PR) among the total subjects.

Time frame
Approximately 1 month after imaging examination

Secondary outcomes

1

Progression-Free Survival（PFS）

The time from treatment initiation to disease progression or death from any cause in cancer patients.

Time frame
Approximately 1 day after disease progression or death from any cause in cancer patients.
2

Disease Control Rate（DCR）

The proportion of patients with tumor shrinkage or stabilization maintained for a certain duration, including those with complete response (CR), partial response (PR), and stable disease (SD).

Time frame
Approximately 1 month after imaging examinatio
3

Overall Survival (OS)

The time from initial treatment to death from any cause

Time frame
Approximately 2 years after last participant enrollment
4

Adverse Event (AE)

Type, incidence, grading (based on NCI-CTCAE v5.0 criteria), and duration of adverse event

Time frame
Approximately 2 month after any treatment

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Provincial Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: