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

NCT05822453 | Not Yet Recruiting Phase 2

• 1 other identifier: BTC-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Baseline up to approximately 6 months

Secondary Outcomes (10)

• Progression free survival (PFS)

  baseline up to approximately 12 months

• 1-year survival rate

  baseline up to approximately 12 months

• Disease control rate (DCR)

  baseline up to approximately 6 months

• Duration of response (DoR)

  baseline up to approximately 12 months

• Percentage of participants with SD ≥ 4 weeks

  baseline up to approximately 6 months

Study Arms (1)

Gemcitabine plus S1 and tislelizumab

EXPERIMENTAL

Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity

Drug: Gemcitabine; Drug: S1; Drug: Tislelizumab

Interventions

Gemcitabine DRUG

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

Gemcitabine plus S1 and tislelizumab

S1 DRUG

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

Gemcitabine plus S1 and tislelizumab

Tislelizumab DRUG

Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle

Gemcitabine plus S1 and tislelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Age ≤ 18 years old ≤ 75 years old, regardless of gender.
• \. Diagnosed as malignant tumor of biliary tract by histopathology or cytology, including intrahepatic cholangiocarcinoma, hilar cholangiocarcinoma, common bile duct carcinoma or gallbladder carcinoma.
• \. The disease is not suitable for radical surgery and/or local treatment;
• \. At least one measurable lesion according to RECIST 1.1 standard
• \. The ECOG score is 0-1
• \. The expected survival ≥ 12 weeks.
• \. The Child-Pugh score is 5-7
• \. 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)
• \. 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%.
• \. Male: Agree to abstain (not engage in heterosexual intercourse) or use contraception, agree not to donate sperm
• \. The subjects voluntarily participated in the study and agreed to sign written informed consent, with good compliance and cooperation in follow-up.

You may not qualify if:

• \. 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
• \. Known to be allergic or intolerant to recombinant humanized PD-1 monoclonal antibody drugs and their components.
• \. ECOG PS ≥ 2
• \. metastasis site\>2 organs
• \. Pregnant or lactating women
• \. 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
• \. Receiving approved or developing systemic anticancer therapies, including chemotherapy, biological immunotherapy, targeted therapy, or Chinese herbal therapy with clear indications for anti-tumor effects
• \. 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)
• \. Simultaneously participating in another clinical study
• \. After comprehensive assessment of the condition by the investigators, it is deemed unsuitable to participate in this study

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Beijing, China

Location

MeSH Terms

Interventions

Gemcitabine; S 1 (combination); tislelizumab

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Haifeng XU

CONTACT

18610431165; xuhf781120@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2023
• First Posted: April 20, 2023
• Study Start: April 30, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2026
• Last Updated: April 20, 2023

Record last verified: 2023-04

Locations

CN (1)