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Trial Title:
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma
NCT ID:
NCT05822453
Condition:
Biliary Tract Carcinoma
Conditions: Official terms:
Carcinoma
Gemcitabine
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each
21-day cycle
Arm group label:
Gemcitabine plus S1 and tislelizumab
Intervention type:
Drug
Intervention name:
S1
Description:
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
Arm group label:
Gemcitabine plus S1 and tislelizumab
Intervention type:
Drug
Intervention name:
Tislelizumab
Description:
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle
Arm group label:
Gemcitabine plus S1 and tislelizumab
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Address:
City:
Beijing
Country:
China
Start date:
April 30, 2023
Completion date:
April 30, 2026
Lead sponsor:
Agency:
Peking Union Medical College Hospital
Agency class:
Other
Source:
Peking Union Medical College Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05822453
