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Biliary Tract CarcinomaPhase 2NCT05668884

GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma

A Phase 2 study testing Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab in people with Biliary Tract Carcinoma, run by Fudan University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Biliary Tract Carcinoma
What is being tested?
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
93 participants
Where
1 siteChina
Study dates
18 Oct 2022to 31 Mar 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

  • Age ≥18 years and ≤75 years;
  • ECOG physical condition score: 0~1;
  • Histologically or cytologically confirmed advanced biliary tract carcinoma (including gallbladder, intrahepatic and extrahepatic cholangiocarcinoma);
  • Preoperative imaging assessment of the disease stage was III/IV;
  • At least one measurable lesion (according to mRECIST criteria)
  • Child-Pugh classification : A or B
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  • The main organs function well, and the examination indicators meet the following requirements:
  • Routine blood tests: Hemoglobin ≥90 g/L (no blood transfusion within 14 days);Neutrophil count ≥1.5×10^9/L; Platelet count ≥80×10^9/L;
  • Biochemical examination: Total bilirubin ≤2×ULN (upper normal value); ALT or AST ≤ 2.5×ULN; Endogenous creatinine clearance ≥ 50 mL /min (Cockcroft-Gault formula);
  • thyroid function:Thyroid function is normal, thyroid stimulating hormone TSH is defined to be within the normal range. If baseline TSH is outside the normal range, T3 and T4 can be included if they are within the normal range;
  • Myocardial enzyme profile:The myocardial enzyme profile was in the normal range (if simple laboratory abnormalities that were not clinically significant as determined by the investigators could also be included);
  • Estimated survival time ≥ 3 months;
  • Sign the informed consent voluntarily;
  • Good compliance, and family members willing to cooperate with follow-up.

Who cannot join

  • Patients with other uncured malignant tumors;
  • Pregnant or lactating women who are required to withdraw from the clinical trial if they become pregnant during the study period;
  • Previous antitumor therapy for the disease in this study;
  • Participated in clinical trials of other drugs within one month;
  • Patients with a known history of other systemic serious diseases before screening;
  • Obstructive jaundice (after active treatment such as biliary drainage or stent, the patients can be included in the group after the liver function returns to normal);
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  • Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal in the clinical laboratory of the study center);
  • Active HCV infected persons (HCV antibody positive with HCV RNA levels above the lower limit of detection);
  • Allergic to any investigational drug or excipient;
  • Long-term unhealed wounds or incomplete healing fractures;
  • Previous organ transplantation history;
  • Having a history of abuse of psychotropic substances and being unable to quit or having mental disorders;
  • A history of immune deficiency or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;
  • Concomitant conditions that, in the investigator's judgment, seriously endanger the patient's safety or affect the patient's completion of the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lu Wang, M.D. contact

86-18121299357

w.lr@hotmail.com

Yiming Zhao, M.D. contact

13917307629

gomas1711@163.com

China1 site, 1 recruiting

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200062

    Lu Wang, M.D., +86-18121299357, w.lr@hotmail.com

    Yiming Zhao, M.D.

    Recruiting

Other trials in China

About this study

Official title: Effects and Safety of GEMOX Combined With Donafenib and Tislelizumab in Advanced Biliary Tract Carcinoma：a Prospective, Single-arm, Multi-center Phase II Study

In this phase 2 study, the investigators aim to evaluate the effects and safety of combined therapy using oxaliplatin and gemcitabine chemotherapy, Donafenib and Tislelizumab for patients with advanced biliary tract carcinoma.

Read the detailed description

Most advanced biliary tract carcinoma (BTC) patients are often accompanied by local or distant metastases and lose the opportunity for surgical resection. For patients with advanced BTC who have been in stages III and IV (AJCC/UICC, V2, 2018), the survival time is less than 4 months, and there is currently no standard treatment. The Gemox chemotherapy (oxaliplatin + gemcitabine) has been used in the treatment of advanced BTC, but the efficacy is still unsatisfactory. Donafenib is a small molecule multi-kinase inhibitor, the main targets including VEGFR1-3, PDGFRα, RET(ret proto-oncogene ), c-KIT(KIT proto-oncogene, receptor tyrosine kinase), Raf,FLT3,have anti-angiogenic effects, have been proven effective in hepatocellular carcinoma. In recent years, monoclonal antibodies against programmed cell death protein 1 (PD1) have shown remarkable therapeutic effects in the treatment of various solid tumors. Prior to this, the combined treatment of GEMOX combined with Donafenib and Tislelizumab was proved satisfying safety. Meanwhile,the phase-I trial showed good efficacy in conversion rate and 6-month overall survival rate. Due to the limitted small sample size of the phase I trial, the investigators aim to expand the sample size to further verify the effects and safety of combined therapy in the study.

Being tested
Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab
Keywords
Donafenib, Tislelizumab, Effects, Safety

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Combination of Gemcitabine, Oxaliplatin, Donafenib and TislelizumabCombination product

    Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks

Study groups in NCT05668884
Study groupRoleWhat they receive
experimental groupExperimentalCombination of Gemox, Donafenib and Tislelizumab
Receives: Combination Product: Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

    objective response rate(ORR)，defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1

    Measured: 6 months

Secondary outcomes (5)

  1. 1-year Recurrence free survival

    1-year Recurrence free survival

    Measured: 1 year

  2. Progression-free survival

    progression-free survival(PFS), defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

    Measured: 6 months

  3. Overall survival

    overall survival(OS), defined as the time from enrollment to death due to any cause.

    Measured: 6 months

  4. Incidence and degree of Adverse Events and Serious Adverse Events

    Incidence, severity, and relationship to study drugs of all adverse events (AEs), treatment-related adverse events (TRAEs), and serious adverse events (SAEs).

    Measured: 6 months

  5. Conversion rate

    Conversion rate, defined as the percentage of the conversion of patients with BTC assessed as unresectable into resectable through interventions, including the conversion of unresectable into resectable in the scientific sense such as insufficient future liver remnant(FLR), as well as the conversion of R1 and R2 to R0.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start18 Oct 2022
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

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
Single Group Assignment
Masking
None (open label)
Enrolment
93 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668884
Sponsor's protocol ID
2209260-22-2407A
Status last verified
Dec 2025
First submitted
12 Dec 2022
Last updated
14 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab in people with Biliary Tract Carcinoma, 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 14 inclusion and 14 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 Jan 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 Lu Wang, M.D. (86-18121299357, w.lr@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668884.

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 Jan 2026.

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