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

Primary Purpose

Biliary Tract Carcinoma

Status
Not yet recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
S1
Tislelizumab
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Biliary Tract Carcinoma

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chinese Academy of Medical Sciences & Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine plus S1 and tislelizumab

Arm Description

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

Outcomes

Primary Outcome Measures

Objective response rate (ORR)

Secondary Outcome Measures

Progression free survival (PFS)
1-year survival rate
Disease control rate (DCR)
Duration of response (DoR)
Percentage of participants with SD ≥ 4 weeks
3-month progression free survival rate
6-month progression free survival rate
6-month overall survival rate
12-month overall survival rate
Quality of life (QoL)

Full Information

First Posted
April 10, 2023
Last Updated
April 10, 2023
Sponsor
Peking Union Medical College Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05822453
Brief Title
Gemcitabine Plus S1 and Tislelizumab in the First Line Therapy of Advanced Biliary Tract Carcinoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 30, 2023 (Anticipated)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Tract Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine plus S1 and tislelizumab
Arm Type
Experimental
Arm Description
Participants will receive gemcitabine plus S1 and tislelizumab until disease progression or unacceptable toxicity
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
Gemcitabine (1000 mg/m2) will be administered by IV infusion on Day 1and Day 8 of each 21-day cycle
Intervention Type
Drug
Intervention Name(s)
S1
Intervention 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
Intervention Type
Drug
Intervention Name(s)
Tislelizumab
Intervention Description
Tislelizumab (200 mg) will be administered by IV infusion on Day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Objective response rate (ORR)
Time Frame
Baseline up to approximately 6 months
Secondary Outcome Measure Information:
Title
Progression free survival (PFS)
Time Frame
baseline up to approximately 12 months
Title
1-year survival rate
Time Frame
baseline up to approximately 12 months
Title
Disease control rate (DCR)
Time Frame
baseline up to approximately 6 months
Title
Duration of response (DoR)
Time Frame
baseline up to approximately 12 months
Title
Percentage of participants with SD ≥ 4 weeks
Time Frame
baseline up to approximately 6 months
Title
3-month progression free survival rate
Time Frame
baseline up to approximately 3 months
Title
6-month progression free survival rate
Time Frame
baseline up to approximately 6 months
Title
6-month overall survival rate
Time Frame
baseline up to approximately 6 months
Title
12-month overall survival rate
Time Frame
baseline up to approximately 12 months
Title
Quality of life (QoL)
Time Frame
baseline up to approximately 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haifeng XU
Phone
18610431165
Email
xuhf781120@sina.com
Facility Information:
Facility Name
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
City
Beijing
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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