The Efficacy and Safety of Anlotinib Plus TQB2450 Combined With Nab-paclitaxel and Cisplatin as First-line Treatment for Advanced Biliary Tract Cancer

The First Affiliated Hospital of Zhengzhou University1 site in 1 country20 target enrollmentApril 10, 2023

ConditionsAdvanced Biliary Tract Cancer

Interventionsanlotinib+TQB2450+nab-paclitaxel+cisplatin

Drugsanlotinib+TQB2450+nab-paclitaxel+cisplatin

Overview

Phase: Phase 2
Intervention: anlotinib+TQB2450+nab-paclitaxel+cisplatin
Conditions: Advanced Biliary Tract Cancer
Sponsor: The First Affiliated Hospital of Zhengzhou University
Enrollment: 20
Locations: 1
Primary Endpoint: Objective Response Rate(ORR)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the efficacy and safety of anlotinib plus TQB2450 combined with nab-paclitaxel and cisplatin as first-line treatment for advanced biliary tract cancer

Registry

clinicaltrials.gov

Start Date

April 10, 2023

End Date

October 10, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital of Zhengzhou University

Responsible Party

Principal Investigator

Hong Zong

Professor of Medicine

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

•Age: 18-75 years old; both male and female are eligible.
•Pathologically confirmed unresectable, untreated gallbladder cancer or intrahepatic/extrahapatic cholangiocarcinoma with at least one measurable lesion according to RECIST v1.
•Tissue samples must be provided for biomarker analysis, preferably newly acquired tissue. If newly acquired tissue is not available, 5-8 archived paraffin sections with a thickness of 5um must be provided.
•ECOG score: 0-
•Expected survival period ≥12 weeks.
•Normal function of major organs, which meets the following criteria: Blood routine test: a) Hb ≥ 90 g/L (no blood transfusion within 14 days); b) ANC ≥ 1.5x 10\^9/L; c) PLT ≥ 80x 10\^9/L; Biochemical test: a) ALB ≥ 30g/L (no albumin transfusion within 14 days); b) ALT and AST \<2.5ULN; if there is liver metastasis, ALT and AST ≤5ULN; c) TBIL ≤ 1.5ULN; d) plasma Cr ≤ 1.5ULN; or creatinine clearance rate (CCr) ≥60ml/min.
•Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%).
•Participants must voluntarily agree to join the study, sign an informed consent form, and be able to comply with the visit and related procedures specified in the protocol. Female participants of childbearing potential or male participants whose partner is of childbearing potential must take effective contraceptive measures throughout the treatment period and for 6 months after the end of treatment.

Exclusion Criteria

•Confirmed allergy to anlotinib hydrochloride and/or its excipients, and TQB-2450 components;
•Uncontrolled hypertension (systolic blood pressure \>140 mmHg, diastolic blood pressure \>90 mmHg), grade I or higher coronary heart disease, grade I arrhythmia (including QTc interval prolongation of \>450 ms in males and \>470 ms in females), and heart failure with urine protein positive;
•Patients with clear gastrointestinal bleeding tendencies, including local active ulcer lesions and fecal occult blood (++), cannot be included. Patients with a history of black stool or vomiting within 2 months cannot be included;
•Patients with abnormal coagulation function (INR \> 1.5, APTT \> 1.5 ULN) with a tendency to bleed;
•Patients with multiple factors affecting oral drug absorption (such as dysphagia, nausea, vomiting, chronic diarrhea, and bowel obstruction, etc.);
•Patients with central nervous system metastases;
•Pregnant or lactating women;
•Patients with other malignant tumors within 5 years (excluding cured skin basal cell carcinoma and cervical intraepithelial neoplasia);
•Patients with a history of substance abuse that cannot be overcome or with mental illness;
•Patients who participated in another drug clinical trial within 4 weeks;