- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05822453
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma
April 10, 2023 updated by: Peking Union Medical College Hospital
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).
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Haifeng XU
- Phone Number: 18610431165
- Email: xuhf781120@sina.com
Study Locations
-
-
-
Beijing, China
- Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Gemcitabine plus S1 and tislelizumab
Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity
|
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
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
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Objective response rate (ORR)
Time Frame: Baseline up to approximately 6 months
|
Baseline up to approximately 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression free survival (PFS)
Time Frame: baseline up to approximately 12 months
|
baseline up to approximately 12 months
|
1-year survival rate
Time Frame: baseline up to approximately 12 months
|
baseline up to approximately 12 months
|
Disease control rate (DCR)
Time Frame: baseline up to approximately 6 months
|
baseline up to approximately 6 months
|
Duration of response (DoR)
Time Frame: baseline up to approximately 12 months
|
baseline up to approximately 12 months
|
Percentage of participants with SD ≥ 4 weeks
Time Frame: baseline up to approximately 6 months
|
baseline up to approximately 6 months
|
3-month progression free survival rate
Time Frame: baseline up to approximately 3 months
|
baseline up to approximately 3 months
|
6-month progression free survival rate
Time Frame: baseline up to approximately 6 months
|
baseline up to approximately 6 months
|
6-month overall survival rate
Time Frame: baseline up to approximately 6 months
|
baseline up to approximately 6 months
|
12-month overall survival rate
Time Frame: baseline up to approximately 12 months
|
baseline up to approximately 12 months
|
Quality of life (QoL)
Time Frame: baseline up to approximately 12 months
|
baseline up to approximately 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
April 30, 2023
Primary Completion (Anticipated)
April 30, 2025
Study Completion (Anticipated)
April 30, 2026
Study Registration Dates
First Submitted
April 10, 2023
First Submitted That Met QC Criteria
April 10, 2023
First Posted (Actual)
April 20, 2023
Study Record Updates
Last Update Posted (Actual)
April 20, 2023
Last Update Submitted That Met QC Criteria
April 10, 2023
Last Verified
April 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Carcinoma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gemcitabine
Other Study ID Numbers
- BTC-001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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