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Anlotinib in Combination With PD1 With Gemcitabine Plus(+)Cisplatin for Unresectable or Metastatic Biliary Tract Cancer

NCT04300959 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-03-09

No results posted yet for this study

Summary

To evaluate the efficacy and safety of Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin Compared With Gemcitabine +Cisplatin as First-line Chemotherapy for Unresectable or Metastatic Biliary Tract Cancer

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin

Gemcitabine:1000mg/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8； Anlotinib : 10mg po qd, days 1-14; Sintilimab: 200mg IV, day 1； 1 cycle = 3 weeks.

DRUG

Gemcitabine Plus(+)Cisplatin

Gemcitabine:1g/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8； 1 cycle = 3 weeks.

Sponsors & Collaborators

  • Zhejiang Cancer Hospital

    lead OTHER

Principal Investigators

  • Jieer Ying · Zhejiang Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-01
Primary Completion
2021-01-31
Completion
2022-01-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04300959 on ClinicalTrials.gov