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Chemotherapy

Tislelizumab（Anti PD-1), Lenvatinib and GEMOX Transformation in the Treatment of Potentially Resectable, Locally Advanced Biliary Tract Cancer

Phase 2
Waitlist Available
Led By Jia Fan
Research Sponsored by Shanghai Zhongshan Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

The aim of this study is to assess the R0 resection rate of tislelizumab combined with Lenvatinib and Gemox chemotherapy in the conversion therapy of potentially resectable locally advanced BTC.

Eligible Conditions
  • Anti-Programmed Death-1 Antibody
  • Gemcitabine and Oxaliplatin
  • Lenvatinib
  • Biliary Tract Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
R0 resection rate
Secondary study objectives
CPR
DCR
MPR
+4 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: PD-1 antibody +Lenvatinib+GemoxExperimental Treatment1 Intervention
Tilelizumab 200mg, d1 Q3W Lenvatinib 8mg, po, qd, Gemox chemotherapy Gemcitabine 1000mg/m2, d1, 8, Q3W, + oxaliplatin 85mg/m2 d1, Q3W

Find a Location

Who is running the clinical trial?

Shanghai Zhongshan HospitalLead Sponsor
649 Previous Clinical Trials
2,511,577 Total Patients Enrolled
1 Trials studying Lenvatinib
178 Patients Enrolled for Lenvatinib
Jia FanPrincipal InvestigatorShanghai Zhongshan Hospital
10 Previous Clinical Trials
2,044 Total Patients Enrolled
~10 spots leftby Dec 2025
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