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AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer

ConditionGallbladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFirst Affiliated Hospital Xi'an Jiaotong University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily provide written informed consent;

Age ≥18 years and ≤75 years at enrollment;

Histologically or cytologically confirmed gallbladder adenocarcinoma;

Radiological assessment meeting any of the following criteria: a. Hepatic invasion requiring extensive hepatectomy that the patient cannot tolerate; b. Biliary tract invasion extending beyond the bifurcation threshold requiring extensive hepatectomy that the patient cannot tolerate; c. Regional lymph node metastasis with fused bulky lymph nodes (maximum short-axis diameter >2 cm) compressing or invading critical blood vessels/biliary tracts, precluding radical lymphadenectomy; d. Primary tumor vascular invasion: main portal vein or left portal branch invasion without feasible vascular reconstruction; proper hepatic artery/common hepatic artery invasion >180°, or invasion <180% combined with mandatory portal vein reconstruction; right portal vein/right hepatic artery invasion with intolerance to extensive hepatectomy;e. Direct invasion of adjacent organs (pancreas, stomach, duodenum, colon);

Disqualifiers

Histological or cytological confirmation of gallbladder non-adenocarcinoma: squamous cell carcinoma, neuroendocrine neoplasm, lymphoma, sarcoma;

Presence of distant metastatic disease at screening;

Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy for gallbladder cancer;

Concurrent other malignant tumors besides gallbladder cancer;

Trial design

Design model

Single group

Treatments tested in this trial

  • AK112

    Drug

    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.

  • Gemcitabine

    Drug

    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.

  • Cisplatin

    Drug

    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.

  • Albumin-Bound Paclitaxel /nab-Paclitaxel

    Drug

    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.

Treatment groups

22 Participants
are divided into 1 treatment group
Group A: AK112 Combined with GAP RegimenExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

R0 Resection Rate

Time frame
Approximately 6 months after treatment initiation

Secondary outcomes

1

Objective Response Rate (ORR)

The proportion of participants achieving complete response (CR) or partial response (PR) according to RECIST version 1.1 criteria after treatment.

Time frame
From the first dose of study treatment until documented disease progression, unacceptable toxicity, or radical surgery, whichever occurs first, assessed up to 24 months.
2

Disease Control Rate (DCR)

The proportion of participants achieving complete response, partial response, or stable disease according to RECIST version 1.1 criteria after treatment.

Time frame
From the first dose of study treatment until documented disease progression, unacceptable toxicity, or radical surgery, whichever occurs first, assessed up to 24 months.
3

Major Pathological Response Rate

The proportion of participants achieving major pathological response after conversion therapy among patients undergoing surgical resection.

Time frame
At the time of radical surgery
4

Progression-Free Survival (PFS)

The time from initiation of treatment to disease progression or death from any cause.

Time frame
Up to 3 years after treatment initiation

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

First Affiliated Hospital Xi'an Jiaotong University

Lead sponsor

Source ClinicalTrials.gov

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