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AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer

NCT07767994 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-08-17

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of AK112 combined with the GAP regimen as conversion therapy for patients with locally advanced gallbladder cancer who are initially considered unsuitable for curative surgery.

The main questions this study aims to answer are:

1. Whether AK112 combined with the GAP regimen can increase the rate of successful R0 radical resection after conversion therapy.
2. Whether this treatment approach can achieve tumor response and disease control with acceptable safety in patients with locally advanced gallbladder cancer.

Participants will receive AK112 combined with gemcitabine, cisplatin, and albumin-bound paclitaxel (GAP regimen) every 21 days for 4-6 treatment cycles. Tumor response will be evaluated by CT or MRI according to RECIST version 1.1 criteria. Patients who become eligible for surgery after multidisciplinary evaluation will undergo radical resection. All participants will be monitored for treatment-related adverse events, disease progression, and survival outcomes during follow-up.

Conditions

  • Gallbladder Cancer

Interventions

DRUG

AK112

AK112 will be administered intravenously at a dose of 20 mg/kg every 3 weeks in combination with gemcitabine, cisplatin, and albumin-bound paclitaxel as conversion therapy for locally advanced gallbladder cancer.

DRUG

Gemcitabine

Gemcitabine is a nucleoside analog chemotherapy agent administered intravenously as part of the GAP regimen. Gemcitabine is administered at the specified dose on days 1 and 8 of each 21-day cycle (Q3W) in combination with AK112, cisplatin, and albumin-bound paclitaxel.

DRUG

Cisplatin

Cisplatin is a platinum-based chemotherapy agent administered intravenously as part of the GAP regimen. Cisplatin is administered at the specified dose on days 1 and 8 of each 21-day cycle (Q3W) in combination with AK112, gemcitabine, and albumin-bound paclitaxel.

DRUG

Albumin-Bound Paclitaxel /nab-Paclitaxel

Albumin-bound paclitaxel is a taxane-based chemotherapy agent administered intravenously as part of the GAP regimen. Albumin-bound paclitaxel is administered at the specified dose on days 1 and 8 of each 21-day cycle (Q3W) in combination with AK112, gemcitabine, and cisplatin.

Sponsors & Collaborators

  • First Affiliated Hospital Xi'an Jiaotong University

    lead OTHER

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
2026-08-28
Primary Completion
2028-06-30
Completion
2028-06-30

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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 NCT07767994 on ClinicalTrials.gov