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Durvalumab Combined With Surufatinib as Maintenance Therapy in Patients With Advanced Biliary Tract Cancer

NCT06255262 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-02-13

No results posted yet for this study

Summary

A Real-World Study of Durvalumab combined with Surufatinib as maintenance therapy in patients with advanced biliary tract cancer whose disease did not progress after completion of first-line Durvalumab combined with Gemcitabine+cisplatin treatment.

Conditions

  • Biliary Tract Cancer

Interventions

DRUG

Surufatinib

(1) Safety introduction phase (6 cases): 250mg, oral, QD,after one cycle of combined treatment, the occurrence of DLT was evaluated: 1) If ≤1person occurs, continue the dose expansion study at that dose level. 2)In the event of DLT\> 1, then the dose of surufatinib was adjusted to 200mg，oral，QD,until disease progression or intolerance of toxicity. (2) Dose expansion phase (24 cases): RP2D, oral, QD,until disease progression or intolerance of toxicity.

DRUG

Durvalumab

1500mg, Q4W.iv.every 28 days; until disease progression or intolerance of toxicity.

Sponsors & Collaborators

  • China Medical University, China

    lead OTHER

Principal Investigators

  • Yunpeng Liu, PhD · First Hospital of China Medical University

  • Xiujuan Qu, PhD · First Hospital of China Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

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 NCT06255262 on ClinicalTrials.gov