Gallbladder CancerPhase 2GALENT-BTNCT06963060
Gem+Nab-P+LEN+TIS for Advanced Unresectable BTC (GALENT-BT)
A Phase 2 study testing Gemcitabine nab-PaclitaxelLenvatinibTislelizumab in people with Gallbladder Cancer and Cholangiocarcinoma, run by Wei Gong at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gallbladder Cancer, Cholangiocarcinoma
- What is being tested?
- Gemcitabine nab-PaclitaxelLenvatinibTislelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 30 Jun 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
- Aged 18-75 years, regardless of gender.
- Histologically or cytologically confirmed, untreated primary advanced unresectable biliary tract malignancies (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic chololiocarcinoma (ECC), and gallbladder cancer (GBC); or untreated recurrent BTC (prior adjuvant/neoadjuvant chemotherapy allowed if completed ≥3 months before recurrence, excluding regimens containing PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib).
- ECOG performance status score 0-1.
- Expected survival ≥3 months.
- At least one measurable target lesion per RECIST v1.1 criteria.
- Adequate organ function:
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- Hematologic: Hemoglobin ≥90 g/L; WBC ≥lower limit of normal (LLN); ANC ≥1.5×10⁹/L; platelets ≥100×10⁹/L.
- Renal: Serum creatinine ≤1.5×ULN; endogenous creatinine clearance rate ≥55 mL/min.
- Hepatic: Total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤3×ULN for intrahepatic BTC or liver metastases; ALT/AST ≤5×ULN for liver metastases).
- Coagulation: INR ≤1.5×ULN; APTT within normal range.
- No prior systemic therapy for advanced BTC (chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hormonal therapy). Patients with post-R2 resection are eligible.
- Negative serum/urine pregnancy test (for women of childbearing potential) and agreement to use contraception during the study and for 6 months post-treatment.
- Willing and able to provide written informed consent.
Who cannot join
- Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disorders, psychiatric conditions).
- Known hypersensitivity or intolerance to study drugs or their excipients.
- Pregnancy, lactation, or refusal to use effective contraception.
- Participation in other clinical trials within 30 days prior to enrollment.
- Inability to understand or unwillingness to sign informed consent.
- Any condition that, in the investigator's judgment, may compromise patient safety or compliance (e.g., severe concurrent illness, abnormal lab results, psychosocial factors).
- Prior use of PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib in adjuvant/neoadjuvant settings.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
Official title: Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine
The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma). The main questions it aims to answer are:
What is the objective response rate (ORR) of this quadruplet regimen as first-line therapy?
Read more
What are the secondary outcomes, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile?
This is a single-arm, open-label, phase II study with no comparison group.
Participants will:
Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks.
Take Lenvatinib (4-8 mg orally daily on Days 1-21).
Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks.
Undergo 6-8 treatment cycles (adjusted for tolerability) with regular imaging, laboratory tests, and safety assessments.
Be followed for 3 years to monitor survival and long-term outcomes.
The study plans to enroll 29 participants and will be conducted at a single center over 36 months.
Read the detailed description
- Study Background Biliary tract malignancies (BTCs), including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC), are aggressive cancers with a 5-year survival rate <5%. Current first-line systemic therapies (e.g., gemcitabine/cisplatin) yield limited efficacy (ORR <30%, median OS ~11.7 months). Preclinical and clinical evidence suggests synergistic effects of combining chemotherapy, anti-angiogenic agents, and immune checkpoint inhibitors. The GALENT-BT trial evaluates a novel quadruplet regimen-Gemcitabine + nab-Paclitaxel + Lenvatinib + Tislelizumab-to improve outcomes in advanced unresectable BTCs.
- Study Objectives Primary Objective: Assess the safety and tolerability of the quadruplet regimen over 8 treatment cycles. Secondary Objectives: Evaluate objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate. Monitor adverse events (AEs), serious adverse events (SAEs), and quality of life (QoL). Exploratory Objectives: Investigate biomarkers (e.g., PD-L1 expression, genetic mutations) and radiomic/pathologic features associated with treatment response.
- Study Design Design: Prospective, single-arm, open-label, single-center, phase II trial. Sample Size: Two-stage enrollment: Stage 1 (Lead-in): 9 participants for initial safety evaluation. If ≤3/9 experience grade ≥3 AEs, proceed to Stage 2. Stage 2 (Expansion): 20 additional participants (total 29 evaluable patients). Duration: 36 months (June 2024-June 2027).
- Study Population Inclusion Criteria: Adults aged 18-75 years with histologically confirmed, untreated, advanced unresectable BTC (GBC/ICC/ECC) or recurrent BTC (≥3 months post-adjuvant therapy). ECOG PS 0-1, measurable disease per RECIST 1.1, adequate organ function. Exclusion Criteria: Prior systemic therapy for advanced BTC, severe comorbidities, pregnancy, or intolerance to study drugs.
- Intervention Regimen: Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle. nab-Paclitaxel: 125 mg/m² IV on Days 1 and 8. Lenvatinib: 4-8 mg orally daily (weight-based dosing) on Days 1-21. Tislelizumab: 200 mg IV on Day 1. Treatment Duration: 6-8 cycles (adjustable for tolerability), followed by 3-year survival follow-up.
- Assessments
Efficacy:
Tumor response evaluated by CT/MRI every 6 weeks using RECIST 1.1.
ORR, DCR, PFS, OS, and surgical conversion rate calculated.
Safety:
AEs/SAEs graded per CTCAE v5.0.
Laboratory monitoring (hematology, liver/renal function, thyroid panels).
QoL: Assessed via EORTC QLQ-HCC18 questionnaire at baseline, treatment cycles, and follow-up.
- Conditions
- Gallbladder Cancer, Cholangiocarcinoma
- Being tested
- Gemcitabine nab-PaclitaxelLenvatinibTislelizumab
- Keywords
- advanced unresectable biliary tract malignancies
- Medical subject headings
- Gallbladder Neoplasms, Cholangiocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gemcitabine nab-PaclitaxelLenvatinibTislelizumabDrug
Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks.
Take Lenvatinib (4-8 mg orally daily on Days 1-21).
Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Gemcitabine ,nab-Paclitaxel,Lenvatinib and Tislelizumab Receives: Drug: Gemcitabine nab-PaclitaxelLenvatinibTislelizumab |
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 8 (each cycle is 21 days)
Secondary outcomes (4)
Surgical Conversion Rate
The proportion of patients whose tumors become resectable after treatment and undergo curative-intent surgery (R0/R1 resection).
Measured: At the end of Cycle 8 (each cycle is 21 days)
Disease control rate (DCR)
he proportion of patients who achieve complete response (CR), partial response (PR), or stable disease (SD)
Measured: At the end of Cycle 8 (each cycle is 21 days)
Overall Survival (OS)
Time from randomization to death from any cause
Measured: The end of the 3-year follow-up period
Progression-Free Survival (PFS)
Time from randomization to disease progression or death
Measured: At the end of disease progression or death during the 3-year follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start1 Jun 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (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
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wei Gong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wei Gong, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06963060
- Sponsor's protocol ID
- XHEC-C-2024-121-2
- Acronym
- GALENT-BT
- Status last verified
- Apr 2025
- First submitted
- 7 Apr 2025
- Last updated
- 8 May 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Xinhua Hospital A Ffiliated to Shanghai Jiaotong University School of Medicine
- ClinicalTrials.gov ID
- NCT06963060
- Acronym / sponsor ID
- GALENT-BT / XHEC-C-2024-121-2
- Conditions
- Gallbladder Cancer, Cholangiocarcinoma
- Keywords
- advanced unresectable biliary tract malignancies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Wei GongUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 8 May 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.
The goal of this clinical trial is to evaluate the efficacy and safety of combining Gemcitabine, nab-Paclitaxel, Lenvatinib, and Tislelizumab in adults aged 18-75 years with advanced unresectable biliary tract malignancies (including gallbladder cancer, intrahepatic cholangiocarcinoma, and extrahepatic cholangiocarcinoma). The main questions it aims to answer are:
What is the objective response rate (ORR) of this quadruplet regimen as first-line therapy?
What are the secondary outcomes, including disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety profile?
This is a single-arm, open-label, phase II study with no comparison group.
Participants will:
Receive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks.
Take Lenvatinib (4-8 mg orally daily on Days 1-21).
Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks.
Undergo 6-8 treatment cycles (adjusted for tolerability) with regular imaging, laboratory tests, and safety assessments.
Be followed for 3 years to monitor survival and long-term outcomes.
The study plans to enroll 29 participants and will be conducted at a single center over 36 months.
Detailed description
- Study Background Biliary tract malignancies (BTCs), including gallbladder cancer (GBC), intrahepatic cholangiocarcinoma (ICC), and extrahepatic cholangiocarcinoma (ECC), are aggressive cancers with a 5-year survival rate <5%. Current first-line systemic therapies (e.g., gemcitabine/cisplatin) yield limited efficacy (ORR <30%, median OS ~11.7 months). Preclinical and clinical evidence suggests synergistic effects of combining chemotherapy, anti-angiogenic agents, and immune checkpoint inhibitors. The GALENT-BT trial evaluates a novel quadruplet regimen-Gemcitabine + nab-Paclitaxel + Lenvatinib + Tislelizumab-to improve outcomes in advanced unresectable BTCs.
- Study Objectives Primary Objective: Assess the safety and tolerability of the quadruplet regimen over 8 treatment cycles. Secondary Objectives: Evaluate objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and surgical conversion rate. Monitor adverse events (AEs), serious adverse events (SAEs), and quality of life (QoL). Exploratory Objectives: Investigate biomarkers (e.g., PD-L1 expression, genetic mutations) and radiomic/pathologic features associated with treatment response.
- Study Design Design: Prospective, single-arm, open-label, single-center, phase II trial. Sample Size: Two-stage enrollment: Stage 1 (Lead-in): 9 participants for initial safety evaluation. If ≤3/9 experience grade ≥3 AEs, proceed to Stage 2. Stage 2 (Expansion): 20 additional participants (total 29 evaluable patients). Duration: 36 months (June 2024-June 2027).
- Study Population Inclusion Criteria: Adults aged 18-75 years with histologically confirmed, untreated, advanced unresectable BTC (GBC/ICC/ECC) or recurrent BTC (≥3 months post-adjuvant therapy). ECOG PS 0-1, measurable disease per RECIST 1.1, adequate organ function. Exclusion Criteria: Prior systemic therapy for advanced BTC, severe comorbidities, pregnancy, or intolerance to study drugs.
- Intervention Regimen: Gemcitabine: 1000 mg/m² IV on Days 1 and 8 of each 21-day cycle. nab-Paclitaxel: 125 mg/m² IV on Days 1 and 8. Lenvatinib: 4-8 mg orally daily (weight-based dosing) on Days 1-21. Tislelizumab: 200 mg IV on Day 1. Treatment Duration: 6-8 cycles (adjustable for tolerability), followed by 3-year survival follow-up.
- Assessments
Efficacy:
Tumor response evaluated by CT/MRI every 6 weeks using RECIST 1.1.
ORR, DCR, PFS, OS, and surgical conversion rate calculated.
Safety:
AEs/SAEs graded per CTCAE v5.0.
Laboratory monitoring (hematology, liver/renal function, thyroid panels).
QoL: Assessed via EORTC QLQ-HCC18 questionnaire at baseline, treatment cycles, and 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 |
|---|---|---|
| Treatment | Experimental | Drug: Gemcitabine nab-PaclitaxelLenvatinibTislelizumabGemcitabine ,nab-Paclitaxel,Lenvatinib and Tislelizumab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Aged 18-75 years, regardless of gender.
- Histologically or cytologically confirmed, untreated primary advanced unresectable biliary tract malignancies (BTC), including intrahepatic cholangiocarcinoma (ICC), extrahepatic chololiocarcinoma (ECC), and gallbladder cancer (GBC); or untreated recurrent BTC (prior adjuvant/neoadjuvant chemotherapy allowed if completed ≥3 months before recurrence, excluding regimens containing PD-1/L1 inhibitors, gemcitabine, nab-paclitaxel, or lenvatinib).
- ECOG performance status score 0-1.
- Expected survival ≥3 months.
- At least one measurable target lesion per RECIST v1.1 criteria.
Key exclusion criteria (7 listed)
- Severe systemic infection or uncontrolled comorbidities (e.g., heart failure, thyroid disorders, psychiatric conditions).
- Known hypersensitivity or intolerance to study drugs or their excipients.
- Pregnancy, lactation, or refusal to use effective contraception.
- Participation in other clinical trials within 30 days prior to enrollment.
- Inability to understand or unwillingness to sign informed consent.
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 nab-PaclitaxelLenvatinibTislelizumabReceive Gemcitabine (1000 mg/m² IV on Days 1 and 8) and nab-Paclitaxel (125 mg/m² IV on Days 1 and 8) every 3 weeks. Take Lenvatinib (4-8 mg orally daily on Days 1-21). Receive Tislelizumab (200 mg IV on Day 1) every 3 weeks. | Drug | Treatment |
Primary outcome
ORR
Time frame: At the end of Cycle 8 (each cycle is 21 days)
The objective response rate (ORR) of this quadruplet regimen as first-line therapy
4 secondary outcomes
Surgical Conversion Rate
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Disease control rate (DCR)
Time frame: At the end of Cycle 8 (each cycle is 21 days)
Overall Survival (OS)
Time frame: The end of the 3-year follow-up period
Progression-Free Survival (PFS)
Time frame: At the end of disease progression or death during the 3-year follow-up period
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 8 May 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.
The record lists no contact. Use the official record to reach the sponsor.
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 nab-PaclitaxelLenvatinibTislelizumab in people with Gallbladder Cancer and Cholangiocarcinoma, run by Wei Gong 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 13 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 8 May 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 8 (each cycle is 21 days)). 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 8 May 2025; AzTrials last refreshed its copy on 6 Nov 2026.