Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma

Biliary Tract Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05822453
• Other study ID #: BTC-001
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 30, 2023
• Est. completion date: April 30, 2026

Study information

• Verified date: April 2023
• Source: Peking Union Medical College Hospital
• Contact: Haifeng XU
• Phone: 18610431165
• Email: xuhf781120[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 30, 2026
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Biliary Tract Carcinoma
• Carcinoma

Intervention

Drug:
• Gemcitabine
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
• S1
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
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle

Locations

Country	Name	City	State
China	Chinese Academy of Medical Sciences & Peking Union Medical College Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate (ORR)		Baseline up to approximately 6 months
Secondary	Progression free survival (PFS)		baseline up to approximately 12 months
Secondary	1-year survival rate		baseline up to approximately 12 months
Secondary	Disease control rate (DCR)		baseline up to approximately 6 months
Secondary	Duration of response (DoR)		baseline up to approximately 12 months
Secondary	Percentage of participants with SD = 4 weeks		baseline up to approximately 6 months
Secondary	3-month progression free survival rate		baseline up to approximately 3 months
Secondary	6-month progression free survival rate		baseline up to approximately 6 months
Secondary	6-month overall survival rate		baseline up to approximately 6 months
Secondary	12-month overall survival rate		baseline up to approximately 12 months
Secondary	Quality of life (QoL)		baseline up to approximately 12 months