Intrahepatic CholangiocarcinomaPhase 2NCT05019677
GP Chemotherapy in Combination With Tislelizumab and Ociperlimab as First-line Treatment in Advanced BTC
A Phase 2 study testing GP+PD-1+Tight in people with Intrahepatic Cholangiocarcinoma, run by Fudan University 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
- Intrahepatic Cholangiocarcinoma
- 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
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 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 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
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- 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, Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Study to Evaluate GP Chemotherapy in Combination With Tislelizumab(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced 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) have 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
- Intrahepatic Cholangiocarcinoma
- Being tested
- GP+PD-1+Tight
- Medical subject headings
- Cholangiocarcinoma
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 | 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: 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: 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 posted25 Aug 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Why it stopped: Repeat registration
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic CholangiocarcinomaStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jia Fan, Fudan University
- Investigators
- Jia Fan, Principal investigator, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05019677
- Sponsor's protocol ID
- zs-BTC
- Status last verified
- Aug 2021
- First submitted
- 18 Aug 2021
- Last updated
- 4 Apr 2022
- 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 4 Apr 2022. 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(Anti-PD-1) and Ociperlimab(Anti-TIGIT) as First-line Treatment in Participants With Unresectable Advanced BTC
- ClinicalTrials.gov ID
- NCT05019677
- Acronym / sponsor ID
- zs-BTC
- Conditions
- Intrahepatic Cholangiocarcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Repeat registration
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 25 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) have 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+TightExperimental: 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. |
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: 12 months
Overall Survival (OS）
Time frame: 24 months
6-months/12-months OS rate
Time frame: 12 months
Adverse Events (AEs)
Time frame: 24 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- 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. 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 Intrahepatic Cholangiocarcinoma, 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 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: withdrawn, as of the sponsor's last update on 4 Apr 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
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 4 Apr 2022.