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Biliary Tract CarcinomaPhase 2NCT05023109

GP Chemotherapy in Combination With Anti-PD-1 and Anti-TIGIT in Unresectable Advanced BTC

A Phase 2 study testing GP+PD-1+Tight in people with Biliary Tract Carcinoma, run by Shanghai Zhongshan Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC). 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?
GP+PD-1+Tight
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
1 Feb 2021to 1 Dec 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

  • • Subjects with a histopathological or cytologically diagnosis of BTC
  • The participants must be required to sign an informed consent
  • At least one measurable lesion (RECIST 1.1)
  • No previous systematic treatment for BTC
  • Child-Pugh Score, Class A
  • ECOG performance status 0 or 1
  • Adequate organ function
  • Life expectancy of at least 3 months

Who cannot join

  • • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
  • Known history of a serious allergy to any monoclonal antibody
  • Known central nervous system metastases and/or leptomeningeal disease prior to treatment
  • Portal hypertension with esophageal or gastric varices within 6 months prior to initiation of treatment
  • Any bleeding or thrombotic disorder within 6 months prior to initiation of treatment
  • Any active malignancy prior to the start of treatment
Show all 9Show fewer
  • Active or history of autoimmune disease
  • Other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation
  • Pregnant or lactating women

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhongshan hospital

    Shanghai, 200032

Other trials in China

About this study

Official title: A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Participants With Unresectable Advanced Biliary Tract Carcinoma (BTC)

This is an open label, multi-center, phaseⅡstudy to evaluate the efficacy and safety of GP (Gemcitabine/Cisplatin) in combination with Tislelizumab and Ociperlimab as first-line treatment in participants with unresectable advanced Biliary Tract Carcinoma (BTC).

Read the detailed description

Biliary Tract Carcinoma (BTC) has an insidious onset, invasiveness, high malignancy, and no specific symptoms in the early stage, and most of them are in the middle and advanced stages at the time of diagnosis and have lost the chance of surgery. For patients with advanced BTC, systemic therapy is currently the main choice, and gemcitabine/cisplatin (GP) is currently the "gold standard" for first-line treatment of advanced BTC, but the efficacy is still unsatisfactory, and more and more clinical practice has found that GP-based combination therapy may have better efficacy.

Previous studies have shown that chemotherapy can improve the immunotherapy microenvironment and may have a synergistic anti-tumor effect in combination with immunotherapy. This study is to explore the efficacy and safety of GP in combination with anti-PD1 antibody (Tislelizumab) and anti-TIGIT antibody (Ociperlimab) as first-line treatment in participants with unresectable advanced BTC.

Being tested
GP+PD-1+Tight

What participants receive

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

  • GP+PD-1+TightDrug

    Drug: Tislelizumab Tislelizumab 200mg IV Q3W

    Other Name:

    BGB-A317 Anti-PD-1 therapy

    Drug: Ociperlimab Ociperlimab 900mg IV Q3W

    Other Name:

    BGB-A1217 Anti-TIGIT therapy

    Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W

Study groups in NCT05023109
Study groupRoleWhat they receive
GP+PD-1+TightExperimentalTislelizumab 200mg IV Q3W + Ociperlimab 900mg IV Q3W + GP (gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W) Gemcitabine/Cisplatin will be administered on D1/D8 in every three weeks cycle and up to 8 cycles. Tislelizumab and Ociperlimab will be administered on D1 in every three weeks cycle, until the disease progression, intolerable toxicity, death, withdrawal of consent.
Receives: Drug: GP+PD-1+Tight

What is being measured

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

  1. Objective response rate (ORR)

    ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs

    Measured: 24 months

Secondary outcomes (7)

  1. Disease control rate (DCR)

    DCR is defined as the proportion of subjects with CR or PR or SD to study drugs

    Measured: 24 months

  2. Duration of response (DoR)

    DoR is defined as the time interval from first meeting response criteria (CR or PR) to confirmed progressive disease (PD) or death, whichever occurs first.

    Measured: 24 months

  3. Progression-free survival (PFS)

    PFS is defined as the time from the date of treatment to the first documented disease progression or death due to any cause, whichever occurs first.

    Measured: 24 months

  4. 6-months/12-months PFS rate

    6-months/12-months PFS rate is defined as the proportion of patients alive and free of disease progression at 6 months/12 months.

    Measured: 6 months/12 months

  5. Overall Survival (OS）

    OS is defined as the time from the treatment until death due to any cause.

    Measured: 24 months

  6. 6-months/12-months OS rate

    OS rate is defined as the proportion of patients who have not experienced death from any cause at 6 months/12 months.

    Measured: 6 months/12 months

  7. Adverse Events (AEs)

    The grade of AEs and the number of patients with AEs are assessed based on CTCAE v5.0

    Measured: 24 months

Timeline

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

  1. First posted26 Aug 2021
  2. Study start1 Feb 2021
  3. Primary completion18 Jan 2023
  4. Study completion1 Dec 2024 (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
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05023109
Sponsor's protocol ID
ZSAB-TOP
Status last verified
Aug 2023
First submitted
20 Aug 2021
Last updated
15 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Shi G, Huang X, Ma L, Li H, Zhong J, Wang J, Gao Q, Guo X, Qiu S, Sun H, Shi Y, Huang X, Wang X, Yi Y, Zhu X, Huang C, Ding Z, Chen Y, He Y, Shen Y, Sun Q, Zhou J, Fan J. First-line tislelizumab and ociperlimab combined with gemcitabine and cisplatin in advanced biliary tract cancer (ZSAB-TOP): a multicenter, single-arm, phase 2 study. Signal Transduct Target Ther. 2025 Aug 21;10(1):260. doi: 10.1038/s41392-025-02356-y.

    PubMed 40835595

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GP+PD-1+Tight in people with Biliary Tract Carcinoma, run by Shanghai Zhongshan Hospital 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 8 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 15 Aug 2023. 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?

Results are not available in the source record.

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?

Objective response rate (ORR) (time frame: 24 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 NCT05023109, which also lists 1 linked publication.

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 15 Aug 2023.

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