Gallbladder Cancer UnresectablePhase 2TRANSFORM-GBCNCT07310069
Gemcitabine and Nab-Paclitaxel Combined With Iparomlimab and Tuvorilimab for Advanced Gallbladder Cancer
A Phase 2 study testing Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili in people with Gallbladder Cancer Unresectable, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer Unresectable
- What is being tested?
- Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2025to 30 Dec 2027
- 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
- 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.
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- 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.
Who cannot join
- 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).
- Pregnancy, lactation, or unwillingness to use contraception.
- Participation in another clinical trial within 30 days before the first dose.
- Unwillingness to participate or inability to provide informed consent.
- Any other condition that, in the investigator's judgment, may affect patient safety or compliance
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer
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.
- Conditions
- Gallbladder Cancer Unresectable
- Being tested
- Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
- Keywords
- gallbladder cancer
- Medical subject headings
- Gallbladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and TuvoriliDrug
Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili
| Study group | Role | What they receive |
|---|---|---|
| Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili | Experimental | Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili Receives: Drug: Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
The objective response rate (ORR) of this quadruplet regimen as first-line therapy
Measured: At the end of Cycle 6 (each cycle is 21 days)
Surgical Conversion Rate
Proportion of patients who achieve successful conversion to radical resection (R0/R1) after systemic therapy.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Secondary outcomes (8)
Downstaging Rate
Proportion of patients whose clinical stage is reduced after conversion therapy.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Pathologic Response Rate
Proportion of patients with pathologic downstaging or major pathologic response in resected specimens
Measured: At the end of Cycle 6 (each cycle is 21 days)
R0 Resection Rate
Proportion of patients who undergo R0 resection among those who receive surgery.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Disease Control Rate (DCR)
Proportion of patients with CR, PR, or stable disease (SD) lasting ≥4 weeks.
Measured: At the end of Cycle 6 (each cycle is 21 days)
Recurrence-Free Survival (RFS)
Proportion of patients without recurrence at 2 years after resection.
Measured: up to 2 years
Overall Survival (OS)
Time from enrollment to death from any cause.
Measured: through study completion,up to 3 years
Adverse Events (AEs) / Serious AEs (SAEs)
Incidence and severity of AEs and SAEs graded by CTCAE v5.0.
Measured: through study completion, up to 30 days
Surgical Safety
Incidence of surgery-related complications (e.g., infection, bleeding, organ dysfunction)
Measured: Perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start1 May 2025
- Primary completion1 May 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gallbladder Cancer UnresectableStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody)
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Gong, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Wei Gong, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310069
- Sponsor's protocol ID
- XHEC-C-2025-111-4
- Acronym
- TRANSFORM-GBC
- Status last verified
- Nov 2025
- First submitted
- 1 Dec 2025
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- 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 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Single-Arm, Multicenter Study of Gemcitabine and Nab-Paclitaxel in Combination With Iparomlimab and Tuvorilimab in Patients With Advanced Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT07310069
- Acronym / sponsor ID
- TRANSFORM-GBC / XHEC-C-2025-111-4
- Conditions
- Gallbladder Cancer Unresectable
- Keywords
- gallbladder cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorilimab (a dual anti-PD-1/CTLA-4 bispecific antibody)
| Arm | Type | Receives |
|---|---|---|
| Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili | Experimental | Drug: Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and TuvoriliTreatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (7 listed)
- 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).
- Pregnancy, lactation, or unwillingness to use contraception.
- Participation in another clinical trial within 30 days before the first dose.
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 |
|---|---|---|
| Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and TuvoriliTreatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili | Drug | Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili |
Primary outcome
ORR
Time frame: At the end of Cycle 6 (each cycle is 21 days)
The objective response rate (ORR) of this quadruplet regimen as first-line therapy
Surgical Conversion Rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Proportion of patients who achieve successful conversion to radical resection (R0/R1) after systemic therapy.
8 secondary outcomes
Downstaging Rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Pathologic Response Rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
R0 Resection Rate
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Disease Control Rate (DCR)
Time frame: At the end of Cycle 6 (each cycle is 21 days)
Recurrence-Free Survival (RFS)
Time frame: up to 2 years
Overall Survival (OS)
Time frame: through study completion,up to 3 years
Adverse Events (AEs) / Serious AEs (SAEs)
Time frame: through study completion, up to 30 days
Surgical Safety
Time frame: Perioperative
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 30 Dec 2025.
- 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.
Wei Gong principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Treatment :Gemcitabine plus Nab-Paclitaxel (AG regimen) in combination with Iparomlimab and Tuvorili in people with Gallbladder Cancer Unresectable, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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 10 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 30 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: At the end of Cycle 6 (each cycle is 21 days)). The study lists 2 primary outcomes in all. 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 30 Dec 2025.