Biliary Tract CarcinomaPhase 2NCT05822453
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma
A Phase 2 study testing Gemcitabine, S1 and Tislelizumab in people with Biliary Tract Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with 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?
- Gemcitabine, S1 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2023to 30 Apr 2026
- 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
- 1. Age ≤ 18 years old ≤ 75 years old, regardless of gender.
- 2. Diagnosed as malignant tumor of biliary tract by histopathology or cytology, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct carcinoma or gallbladder carcinoma.
- 3. The disease is not suitable for radical surgery and/or local treatment;
- 4. At least one measurable lesion according to RECIST 1.1 standard
- 5. The ECOG score is 0-1
- 6. The expected survival ≥ 12 weeks.
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- 7. The Child-Pugh score is 5-7
- 8. Within the past 2 years, there was no active autoimmune diseases that require systemic treatment, replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary dysfunction)
- 9. Women with fertility: agree to abstain during treatment and at least 6 months after the last dose (to avoid heterosexual intercourse) or use contraceptive methods with an annual contraceptive failure rate of less than 1%.
- 10. Male: Agree to abstain (not engage in heterosexual intercourse) or use contraception, agree not to donate sperm
- 11. The subjects voluntarily participated in the study and agreed to sign written informed consent, with good compliance and cooperation in follow-up.
Who cannot join
- 1. who have any of the following: (1) suitable for surgical radical treatment, (2) have undergone radical surgery without assessable lesions, (3) have received first-line systemic treatment
- 2. Known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components.
- 3. ECOG PS ≥ 2
- 4. metastasis site>2 organs
- 5. Pregnant or lactating women
- 6. Received local anti-tumor therapy within 4 weeks prior to the first study drug treatment, including but not limited to radiotherapy, radiofrequency ablation, cryoablation, or percutaneous ethanol injection
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- 7. Receiving approved or developing systemic anticancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or Chinese herbal therapy with clear indications for anti-tumor effects
- 8. There are multiple factors that can affect the oral administration of S1 (such as inability to swallow, chronic diarrhea, intestinal obstruction, or other conditions that significantly affect drug administration and absorption)
- 9. Simultaneously participating in another clinical study
- 10. After comprehensive assessment of the condition by the investigators, it is deemed unsuitable to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Beijing
About this study
Official title: Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma (BTC): a Single Arm, Prospective, Interventional Clinical Study
This study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).
- Conditions
- Biliary Tract Carcinoma
- Being tested
- Gemcitabine, S1, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GemcitabineDrug
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
S1Drug
S1 (60 mg/day if body surface area < 1.25 m2, 80 mg/day if body surface area = 1.25~1.50 m2) will be administered by PO on Day 1 ~ 14 of each 21-day cycle
TislelizumabDrug
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine plus S1 and tislelizumab | Experimental | Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity Receives: Drug: Gemcitabine; Drug: S1; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
Measured: Baseline up to approximately 6 months
Secondary outcomes (10)
Progression free survival (PFS)
Measured: baseline up to approximately 12 months
1-year survival rate
Measured: baseline up to approximately 12 months
Disease control rate (DCR)
Measured: baseline up to approximately 6 months
Duration of response (DoR)
Measured: baseline up to approximately 12 months
Percentage of participants with SD ≥ 4 weeks
Measured: baseline up to approximately 6 months
3-month progression free survival rate
Measured: baseline up to approximately 3 months
6-month progression free survival rate
Measured: baseline up to approximately 6 months
6-month overall survival rate
Measured: baseline up to approximately 6 months
12-month overall survival rate
Measured: baseline up to approximately 12 months
Quality of life (QoL)
Measured: baseline up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2023
- Study start30 Apr 2023 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05822453
- Sponsor's protocol ID
- BTC-001
- Status last verified
- Apr 2023
- First submitted
- 10 Apr 2023
- Last updated
- 20 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma (BTC): a Single Arm, Prospective, Interventional Clinical Study
- ClinicalTrials.gov ID
- NCT05822453
- Acronym / sponsor ID
- BTC-001
- Conditions
- Biliary Tract Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 30 Apr 2023 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 20 Apr 2023 (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 study will evaluate the efficacy and safety of 1st line therapy with gemcitabine plus S1 and tislelizumab in participants with advanced biliary tract carcinoma (BTC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine plus S1 and tislelizumab | Experimental | Drug: Gemcitabine, Drug: S1, Drug: TislelizumabParticipants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age ≤ 18 years old ≤ 75 years old, regardless of gender.
- 2. Diagnosed as malignant tumor of biliary tract by histopathology or cytology, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct carcinoma or gallbladder carcinoma.
- 3. The disease is not suitable for radical surgery and/or local treatment;
- 4. At least one measurable lesion according to RECIST 1.1 standard
- 5. The ECOG score is 0-1
Key exclusion criteria (10 listed)
- 1. who have any of the following: (1) suitable for surgical radical treatment, (2) have undergone radical surgery without assessable lesions, (3) have received first-line systemic treatment
- 2. Known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components.
- 3. ECOG PS ≥ 2
- 4. metastasis site>2 organs
- 5. Pregnant or lactating women
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 |
|---|---|---|
| GemcitabineGemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle | Drug | Gemcitabine plus S1 and tislelizumab |
| S1S1 (60 mg/day if body surface area < 1.25 m2, 80 mg/day if body surface area = 1.25~1.50 m2) will be administered by PO on Day 1 ~ 14 of each 21-day cycle | Drug | Gemcitabine plus S1 and tislelizumab |
| TislelizumabTislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle | Drug | Gemcitabine plus S1 and tislelizumab |
Primary outcome
Objective response rate (ORR)
Time frame: Baseline up to approximately 6 months
10 secondary outcomes
Progression free survival (PFS)
Time frame: baseline up to approximately 12 months
1-year survival rate
Time frame: baseline up to approximately 12 months
Disease control rate (DCR)
Time frame: baseline up to approximately 6 months
Duration of response (DoR)
Time frame: baseline up to approximately 12 months
Percentage of participants with SD ≥ 4 weeks
Time frame: baseline up to approximately 6 months
3-month progression free survival rate
Time frame: baseline up to approximately 3 months
6-month progression free survival rate
Time frame: baseline up to approximately 6 months
6-month overall survival rate
Time frame: baseline up to approximately 6 months
12-month overall survival rate
Time frame: baseline up to approximately 12 months
Quality of life (QoL)
Time frame: baseline up to approximately 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2023.
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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.
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, S1 and Tislelizumab in people with Biliary Tract Carcinoma, run by Peking Union Medical College 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 11 inclusion and 10 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 20 Apr 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?
Contact Haifeng XU (18610431165, xuhf781120@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Baseline up to approximately 6 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 20 Apr 2023.