Gallbladder Cancer UnresectablePhase 2GCNDNCT06591650
Gemcitabine Hydrochloride, Cisplatin, Nab-Paclitaxel, and Durvalumab in Treating Patients With Locally Advanced or Metastatic Gallbladder Cancer
A Phase 2 study testing gemcitabine hydrochloride, Cisplatin and Nab-paclitaxel in people with Gallbladder Cancer Unresectable, run by Fudan University at 1 site in China.
Trial summary
This phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gallbladder Cancer Unresectable
- What is being tested?
- gemcitabine hydrochloride, Cisplatin and Nab-paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteChina
- Study dates
- 24 Oct 2024to 30 Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years at time of study entry.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma.
- Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
- Has a life expectancy ≥ 3 months from proposed first dose date.
- Has received no prior anti-cancer therapy for gallbladder adenocarcinoma.
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- Has adequate bone marrow, liver and renal functions measured within 14 days prior to administration of study treatment: Absolute neutrophil count≥1.5 x109/L;Platelet count≥100×109/L;Serum bilirubin≤2.5×institutional upper limit of normal (ULN). Subjects requiring biliary decompression, biliary stent, or drainage using percutaneous trans-hepatic cholangiogram are allowed (patients with a declining bilirubin status post stent placement are eligible with serum bilirubin≤2.5×ULN);Aspartate aminotransferase (AST)/alanine aminotransferase (ALT)≤2.5×ULN;Measured creatinine clearance (CL)>50 mL/min or calculated creatinine CL\> 50 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance.
- Women with childbearing potential should complete a pregnancy test with negative result within 28 days of study treatment and be willing to use effective contraceptive methods from screening to 90 days after the last dose of durvalumab
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm from screening to 90 days after the last dose of durvalumab.
- Capable of giving written informed consent, prior to any study specific procedures,and ability to comply with the study protocol in the investigator\'s judgment.
Who cannot join
- Diagnosis of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or carcinoma of Vaters ampulla.
- Known hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients, who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 therapy.
- Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn\'s disease], diverticulitis [diverticulosis is not an excluding factor], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves\' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
- Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; Patients having any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years (allowed only after consultation with the study physician); Patients with celiac disease controlled by diet alone.
- Has history of allogenic organ transplantation.
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- Has a history of active primary immunodeficiency.
- Has uncontrolled intercurrent illness, including but not limited to, ongoing or active infection; symptomatic congestive heart failure; uncontrolled hypertension; unstable angina pectoris; cardiac arrhythmia; interstitial lung disease; serious chronic gastrointestinal conditions associated with diarrhea; or psychiatric illness/social situations that would limit compliance with study requirements, would substantially increase risk of incurring adverse events (AEs), or would compromise the ability of the patient to give written informed consent.
- Has a prior history of myocardial infarction, transient ischemic attack, or stroke within the past 3 months prior to the scheduled first dose of study treatment.
- Has a history of another primary malignancy. Patients having the following are still eligible: Malignancy treated with curative intent, no known active disease \>= 5 years before the first dose of IP, and low potential risk for recurrence; Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; Adequately treated carcinoma in situ without evidence of disease.
- Has active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (presence of hepatitis B surface antigen [HBsAg] and/or anti-HBcAb with detectable hepatitis B virus [HBV] DNA ≥10 IU/mL), or hepatitis C. Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
- Is currently using or previously used immunosuppressive medication within 14 days before the first dose of durvalumab. The following medications are exceptions to this criterion: Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra articular injection); Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent; Steroids as premedication for hypersensitivity reactions (e.g., computed tomography [CT] scan premedication).
- Is a female and pregnant or breastfeeding; or is a male or female of reproductive potential who is not willing to employ effective birth control from time of screening to 90 days after the last dose of durvalumab.
- Participated in another clinical study with an investigational product during the last 4 weeks from the first dose of this study\'s treatment.
- Is concurrently enrolled in another clinical study (patient is eligible if the study is an observational (non interventional) study or if enrollment is during the follow-up period of an interventional study.
- Is unsuitable to participate in the study or is unlikely to comply with study procedures, restrictions and requirements (per judgment by the investigator).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shenghao Wang contact
China1 site, 1 recruiting
- Recruiting
Hepatobiliary Surgery Center, Department of General Surgery, Huashan Hospital & Cancer Metastasis Institute, Fudan University
Shanghai, Shanghai Municipality, 200040
Xiangyu Wang, Dr, 18317086082, wangxymed@163.com
Shenghao Wang, Dr, 18019491524, shenghaow@126.com
About this study
Official title: A Phase II Study of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Durvalumab in Locally Advanced or Metastatic Gallbladder Cancer
This phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer.
Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab is a type of drug called a monoclonal antibody, which selectively blocks PD-L1 binding to PD-1. This anti-PD-L1 treatment works by allowing the immune system to detect your cancer and reactivates the immune response.
- Conditions
- Gallbladder Cancer Unresectable
- Being tested
- gemcitabine hydrochloride, Cisplatin, Nab-paclitaxel, Durvalumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
800 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
CisplatinDrug
25 mg/m^2, intravenous (IV) over 60 minutes, Days 1,8, every 21 days.
Nab-paclitaxelDrug
100 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days.
DurvalumabDrug
1500mg, intravenous (IV) over 30 minutes, Days 1, every 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab | Experimental | Patients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes and nab-paclitaxel over 30 minutes on days 1 and 8. Durvalumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: gemcitabine hydrochloride; Drug: Cisplatin; Drug: Nab-paclitaxel; Drug: Durvalumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR)
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
Measured: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
Secondary outcomes (4)
Progressive-free survival (PFS)
PFS based on investigator assessments according to RECIST version 1.1 was defined as time from date of treatment until date of objective disease progression or death (by any cause in the absence of progression), regardless of whether the patient withdrew from therapy or received another anticancer therapy prior to progression. Progression (i.e., PD) was defined as at least a 20% increase in the sum of diameters of target lesions (TLs) and an absolute increase of ≥ 5mm, taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters, or a measurable increase in a non-target lesion, or the appearance of new lesions. Median PFS was calculated using the Kaplan-Meier technique.
Measured: Tumor assessments every 6 weeks after treatment for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 36 months.
Overall Survival (OS)
Overall Survival (OS) was defined as the time from the date of treatment until death due to any cause. Any patient not known to have died at the time of analysis was censored based on the last recorded date on which the patient was known to be alive. Median OS was calculated using the Kaplan-Meier technique.
Measured: From date of treatment until death due to any cause. Assessed up to maximum of approximately 36 months.
Duration of Response (DoR)
The DoR was defined as the time from the date of first documented OR (confirmed CR or confirmed PR) until date of documented progression (PD) based on investigator assessments by using RECIST version 1.1 or death in absence of disease progression. A confirmed CR was defined in above outcome measures. The PD was defined at least 20% increase in sum of diameters of target lesions, unequivocal progression of existing non-target lesions or new lesion. For participants who were alive and no documented PD at the time of data cutoff for analysis, DoR was censored at the last evaluable disease assessment date. Median DoR was calculated using Kaplan-Meier method.
Measured: Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of treatment and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
Disease Control Rate (DCR)
Disease control rate based on investigator assessments according to RECIST version 1.1 was defined as the rate of best objective response of complete response (CR), partial response (PR) or stable disease (SD).
Measured: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of treatment and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start24 Oct 2024
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 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 Fudan UniversityThe 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
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lunxiu Qin, Fudan University
- Investigators
- Lun xiu Qin, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06591650
- Sponsor's protocol ID
- Huashan010
- Acronym
- GCND
- Status last verified
- May 2026
- First submitted
- 8 Sep 2024
- Last updated
- 14 May 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Gemcitabine, Cisplatin, Nab-Paclitaxel, and Durvalumab in Locally Advanced or Metastatic Gallbladder Cancer
- ClinicalTrials.gov ID
- NCT06591650
- Acronym / sponsor ID
- GCND / Huashan010
- Conditions
- Gallbladder Cancer Unresectable
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (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 phase II trail will evaluate the efficacy and safety of combining gemcitabine hydrochloride, cisplatin, nab-paclitaxel (paclitaxel albumin-stabilized nanoparticle formulation), with durvalumab in treating patients who have locally advanced or metastatic gallbladder cancer.
Drugs used in chemotherapy, such as gemcitabine hydrochloride, cisplatin, and nab-paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Durvalumab is a type of drug called a monoclonal antibody, which selectively blocks PD-L1 binding to PD-1. This anti-PD-L1 treatment works by allowing the immune system to detect your cancer and reactivates the immune response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab | Experimental | Drug: gemcitabine hydrochloride, Drug: Cisplatin, Drug: Nab-paclitaxel, Drug: DurvalumabPatients receive gemcitabine hydrochloride intravenously (IV) over 30 minutes, cisplatin IV over 60 minutes and nab-paclitaxel over 30 minutes on days 1 and 8. Durvalumab intravenously (IV) on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age≥18 years at time of study entry.
- Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Has histologically or cytologically confirmed unresectable locally advanced or metastatic gallbladder adenocarcinoma.
- Has at least 1 measurable disease, as defined by RECIST 1.1, at baseline.
- Has a life expectancy ≥ 3 months from proposed first dose date.
Key exclusion criteria (16 listed)
- Diagnosis of intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma or carcinoma of Vaters ampulla.
- Known hypersensitivity to any of the study drugs or any of the study drug excipients.
- Patients, who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4 therapy.
- Has an active or previously documented autoimmune or inflammatory disorder (including inflammatory bowel disease [e.g., colitis or Crohn\'s disease], diverticulitis [diverticulosis is not an excluding factor], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves\' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]).
- Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone replacement therapy) is acceptable: Patients with vitiligo or alopecia; Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; Patients having any chronic skin condition that does not require systemic therapy; Patients without active disease in the last 5 years (allowed only after consultation with the study physician); Patients with celiac disease controlled by diet alone.
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 |
|---|---|---|
| gemcitabine hydrochloride800 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days. | Drug | Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab |
| Cisplatin25 mg/m^2, intravenous (IV) over 60 minutes, Days 1,8, every 21 days. | Drug | Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab |
| Nab-paclitaxel100 mg/m^2, intravenous (IV) over 30 minutes, Days 1,8, every 21 days. | Drug | Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab |
| Durvalumab1500mg, intravenous (IV) over 30 minutes, Days 1, every 21 days. | Drug | Gemcitabine + Cisplatin + Nab-Paclitaxel + Durvalumab |
Primary outcome
Objective Response Rate (ORR)
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
Disease assessments based on investigator assessments were determined by using RECIST version 1.1 guidelines. The ORR was defined as the percentage of patients with confirmed complete response (CR) or confirmed partial response (PR). The CR was defined as disappearance of all target and non-target lesions and no new lesions. The PR was defined as ≥ 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new non-target lesion. A confirmed CR or PR was defined as 2 CRs or 2 PRs with no evidence of progression in-between. Patients who discontinued randomized treatment without progression, received a subsequent anti-cancer therapy and then responded were not included as responders for ORR.
4 secondary outcomes
Progressive-free survival (PFS)
Time frame: Tumor assessments every 6 weeks after treatment for the first 24 weeks and then every 8 weeks thereafter until date of RECIST 1.1 defined radiological progressive disease or death. Assessed up to maximum of approximately 36 months.
Overall Survival (OS)
Time frame: From date of treatment until death due to any cause. Assessed up to maximum of approximately 36 months.
Duration of Response (DoR)
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for first 24 weeks relative to the date of treatment and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
Disease Control Rate (DCR)
Time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of treatment and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.
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 14 May 2026.
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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.
Shenghao Wang contact
Lun xiu Qin principal investigator
Fudan University
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 gemcitabine hydrochloride, Cisplatin and Nab-paclitaxel in people with Gallbladder Cancer Unresectable, run by Fudan University 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 16 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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?
Contact Xiangyu Wang (18317086082 ext. 86-18317086082, wangxymed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) (time frame: Tumor assessments (per RECIST 1.1) every 6 weeks for the first 24 weeks relative to the date of randomization and then every 8 weeks thereafter. Assessed up to maximum of approximately 36 months.). 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 14 May 2026.