NCT07310069Enrolling by invitationPhase 2
Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer
A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer
Source: ClinicalTrials.gov · Last updated 30 Dec 2025
Brief summary (registry, in English)
This is a single-arm, multicenter, Phase II clinical trial evaluating the efficacy and safety of Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody) in patients with advanced unresectable gallbladder cancer. The study aims to assess the surgical conversion rate and objective response rate (ORR) as primary endpoints. Secondary endpoints include R0 resection rate, disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profiles. A total of 44 participants will be enrolled across three centers in China. The study is scheduled to run from May 2025 to April 2027.
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- First submitted
- 1 Dec 2025
- Start date
- 1 May 2025
- Primary completion date
- 1 May 2027
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT07310069
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 44
- From 1 May 2025 to the primary completion date, 1 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial within 30 days before the first dose.
Other illness
- Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disease, psychiatric disorders); active autoimmune disease requiring medication.
- Known allergy or intolerance to chemotherapy agents.
- Prior antitumor therapy (chemotherapy, radiotherapy, immunotherapy) within the past year, or history of other malignancies (except cured cervical carcinoma in situ or non-melanoma skin cancer).
- Any other condition that, in the investigator's judgment, may affect patient safety or compliance
Other
- Pregnancy, lactation, or unwillingness to use contraception.
- Unwillingness to participate or inability to provide informed consent.
Who the study is looking for
- Signed informed consent.
- Age 18-75 years.
- ECOG performance status 0-2, Child-Pugh class A.
- Histologically or cytologically confirmed advanced gallbladder cancer, deemed unresectable for R0 resection.
- Adequate organ function:
- ANC ≥1.5×10⁹/L, platelets ≥75×10⁹/L, hemoglobin ≥90 g/L.
- Serum creatinine ≤1.2 mg/dL or creatinine clearance ≥60 mL/min.
- Total bilirubin ≤1.5×ULN (≤3×ULN if liver metastases); AST/ALT ≤3×ULN (≤5×ULN if liver metastases).
- Life expectancy ≥3 months.
- Non-pregnant, non-lactating women and willingness to use contraception during and for 3 months after treatment.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xinhua hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.