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.
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.
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.
- Conditions
- Biliary Tract Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| GP+PD-1+Tight | Experimental | Tislelizumab 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.
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)
Disease control rate (DCR)
DCR is defined as the proportion of subjects with CR or PR or SD to study drugs
Measured: 24 months
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
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
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
Overall Survival (OS）
OS is defined as the time from the treatment until death due to any cause.
Measured: 24 months
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
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.
- First posted26 Aug 2021
- Study start1 Feb 2021
- Primary completion18 Jan 2023
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jining Medical University, Cancer Hospital of Guangxi Medical University
- Responsible party
- Sponsor
- Investigators
- Jia Fan, Principal investigator, Shanghai Zhongshan Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05023109
- Acronym / sponsor ID
- ZSAB-TOP
- Conditions
- Biliary Tract Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Jining Medical University, Cancer Hospital of Guangxi Medical University
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 26 Aug 2021 (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 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).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GP+PD-1+Tight | Experimental | Drug: GP+PD-1+TightTislelizumab 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • Subjects with a histopathological or cytologically diagnosis of BTC
Key exclusion criteria (9 listed)
- • Diagnosis of mixed ampullary, hepatocellular, and cholangiocarcinoma
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 |
|---|---|---|
| GP+PD-1+TightDrug: 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 | Drug | GP+PD-1+Tight |
Primary outcome
Objective response rate (ORR)
Time frame: 24 months
ORR is defined as the proportion of subjects with complete response (CR) or partial response (PR) to study drugs
7 secondary outcomes
Disease control rate (DCR)
Time frame: 24 months
Duration of response (DoR)
Time frame: 24 months
Progression-free survival (PFS)
Time frame: 24 months
6-months/12-months PFS rate
Time frame: 6 months/12 months
Overall Survival (OS）
Time frame: 24 months
6-months/12-months OS rate
Time frame: 6 months/12 months
Adverse Events (AEs)
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Derived from this study: PubMed 40835595Shi 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.
- Individual participant dataSharing planned: No
Related trials for Biliary Tract Carcinoma
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At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
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Durvalumab and Tremelimumab in Combination With Propranolol and Chemotherapy for Treatment of Advanced Hepatopancreabiliary Tumors (BLOCKED)
Pancreatic Cancer, Hepatocellular Cancer
Not yet recruitingPhase 3
Hepatic Arterial Infusion Chemotherapy Versus Capecitabine as Adjuvant Therapy for Resected Biliary Tract Cancer
Biliary Tract Cancer, Cholangiocarcinoma
RecruitingPhase 2
MP0317 in Combination With Chemoimmunotherapy in First Line Treatment for Patients With Advanced Biliary Tract Carcinoma
Advanced Biliary Tract Carcinoma
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. This study is not recruiting at the moment.
Jia Fan principal investigator
Shanghai Zhongshan Hospital
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 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.