Gallbladder CancerPhase 2ICORE-GBCNCT07767994
AK112 Combined With GAP Conversion Therapy for Locally Advanced Gallbladder Cancer
A Phase 2 study testing AK112, Gemcitabine and Cisplatin in people with Gallbladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer
- What is being tested?
- AK112, Gemcitabine and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 28 Aug 2026to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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);
- MDT consensus confirming initial non-resectability, with anticipated feasibility of radical resection after conversion therapy;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
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- No prior systemic anti-tumor therapy for locally advanced gallbladder cancer;
- At least one measurable target lesion per RECIST v1.1 suitable for repeated accurate quantitative measurement;
- Adequate organ function to tolerate the conversion regimen;
- Estimated survival ≥3 months;
- Willing and able to comply with scheduled visits, treatment regimens, laboratory testing, and all other study requirements;
- Adequate hematologic, renal, hepatic, coagulation, and cardiac function confirmed by screening laboratory tests (no blood product/growth factor support within 7 days prior to screening lab draws):
- Hematology: i. Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L (1,500/mm³) ii. Platelet count ≥100 × 10⁹/L (100,000/mm³) iii. Hemoglobin ≥90 g/L; b. Renal function: i. Calculated Creatinine Clearance (CrCl) ≥50 mL/min via the Cockcroft-Gault formula: CrCl (mL/min) = [(140 - Age) × Weight (kg) × F] / [Serum Creatinine (mg/dL) × 72] F = 1 for males, F = 0.85 for females; SCr = serum creatinine. ii. Urine protein ≤1+ or 24-hour urine protein quantification <1.0 g; c. Hepatic function: i. Total bilirubin (TBil) ≤ 2 × the upper limit of normal (ULN); ii. AST and ALT ≤2.5 × ULN; iii. Serum Albumin (ALB) ≥28 g/L; d. Coagulation function: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN; e. Cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥50% on echocardiogram.
Who cannot join
- 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;
- Severe uncontrolled biliary tract infection or untreated obstructive jaundice;
- Major surgery or severe trauma within 30 days prior to first study drug administration:
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- Definitions:
- Major surgery: All open/laparoscopic procedures requiring general endotracheal anesthesia entering thoracic, abdominal, or pelvic cavities (e.g.,, exploratory laparotomy, gastrointestinal resection, hernia repair, partial hepatectomy); Severe trauma: Deep tissue injury, visceral rupture requiring hospitalization or surgical repair (e.g., fractures, extensive soft-tissue contusion, closed abdominal trauma);
- Minimally invasive/interventional procedures permitted with mandatory washout intervals:
- Diagnostic biopsy (lymph node, liver/gallbladder fine needle, EUS biopsy): minimum 7 days between the procedure and the first drug administration, no active hemorrhage/hematoma; Biliary decompression (PTCD, ERCP stent/nasobiliary drainage): a minimum of 14 days between the procedure and the first drug administration, no active hemorrhage, peritonitis, or biliary leakage confirmed by clinical and radiological evaluation;
- Active autoimmune disease, active inflammatory bowel disease, congenital or acquired immunodeficiency, active pulmonary tuberculosis, active syphilis infection, prior solid organ or allogeneic hematopoietic stem cell transplantation, or non-infectious interstitial lung disease requiring long-term systemic corticosteroid therapy;
- Severe bleeding diathesis or coagulation disorder history:
- Screening lab abnormalities: PLT <100 ×10⁹/L; INR >1.5 (without anticoagulation); APTT >1.5 × ULN; Fibrinogen <1.5 g/L;
- CTCAE Grade ≥2 active bleeding event within 3 months before enrollment, or uncontrolled major vascular complications;
- Confirmed hypersensitivity to any excipient or active component of the study drugs;
- Pregnant or lactating female patients;
- Severe psychiatric disorder, history of substance dependence, or other medical conditions that may impair trial compliance throughout study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Single-Center, Single-Arm, Two-Stage, Prospective Phase II Clinical Study of AK112 Combined With GAP Regimen as Conversion Therapy for Locally Advanced Gallbladder Cancer
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:
Read more
- Whether AK112 combined with the GAP regimen can increase the rate of successful R0 radical resection after conversion therapy.
- 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
- Being tested
- AK112, Gemcitabine, Cisplatin, Albumin-Bound Paclitaxel /nab-Paclitaxel
- Keywords
- Locally advanced gallbladder cancer, Conversion therapy, AK112
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AK112Drug
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.
GemcitabineDrug
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.
CisplatinDrug
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-PaclitaxelDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| AK112 Combined with GAP Regimen | Experimental | Not described Receives: Drug: AK112; Drug: Gemcitabine; Drug: Cisplatin; Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
R0 Resection Rate
Measured: Approximately 6 months after treatment initiation
Secondary outcomes (5)
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.
Measured: From the first dose of study treatment until documented disease progression, unacceptable toxicity, or radical surgery, whichever occurs first, assessed up to 24 months.
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.
Measured: From the first dose of study treatment until documented disease progression, unacceptable toxicity, or radical surgery, whichever occurs first, assessed up to 24 months.
Major Pathological Response Rate
The proportion of participants achieving major pathological response after conversion therapy among patients undergoing surgical resection.
Measured: At the time of radical surgery
Progression-Free Survival (PFS)
The time from initiation of treatment to disease progression or death from any cause.
Measured: Up to 3 years after treatment initiation
Overall Survival (OS)
The time from initiation of treatment to death from any cause.
Measured: Up to 3 years after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study start28 Aug 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geng Zhimin, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767994
- Sponsor's protocol ID
- IIT-20260310
- Acronym
- ICORE-GBC
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Center, Single-Arm, Two-Stage, Prospective Phase II Clinical Study of AK112 Combined With GAP Regimen as Conversion Therapy for Locally Advanced Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT07767994
- Acronym / sponsor ID
- ICORE-GBC / IIT-20260310
- Conditions
- Gallbladder Cancer
- Keywords
- Locally advanced gallbladder cancer, Conversion therapy, AK112
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Whether AK112 combined with the GAP regimen can increase the rate of successful R0 radical resection after conversion therapy.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AK112 Combined with GAP Regimen | Experimental | Drug: AK112, Drug: Gemcitabine, Drug: Cisplatin, Drug: Albumin-Bound Paclitaxel /nab-Paclitaxel |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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);
- MDT consensus confirming initial non-resectability, with anticipated feasibility of radical resection after conversion therapy;
Key exclusion criteria (17 listed)
- 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;
- Severe uncontrolled biliary tract infection or untreated obstructive jaundice;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AK112AK112 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 | AK112 Combined with GAP Regimen |
| GemcitabineGemcitabine 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 | AK112 Combined with GAP Regimen |
| CisplatinCisplatin 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 | AK112 Combined with GAP Regimen |
| Albumin-Bound Paclitaxel /nab-PaclitaxelAlbumin-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. | Drug | AK112 Combined with GAP Regimen |
Primary outcome
R0 Resection Rate
Time frame: Approximately 6 months after treatment initiation
5 secondary outcomes
Objective Response Rate (ORR)
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.
Disease Control Rate (DCR)
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.
Major Pathological Response Rate
Time frame: At the time of radical surgery
Progression-Free Survival (PFS)
Time frame: Up to 3 years after treatment initiation
Overall Survival (OS)
Time frame: Up to 3 years after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AK112, Gemcitabine and Cisplatin in people with Gallbladder Cancer, run by First Affiliated Hospital Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Geng (13772175199, gengzhimin@mail.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R0 Resection Rate (time frame: Approximately 6 months after treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.