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

NCT05812430 | Unknown Phase 2

• 1 other identifier: BTC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Advanced Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  The RECIST1.1 standards were used to evaluate the efficacy of drugs.

  about 2 years

Secondary Outcomes (3)

• Progression Free Survival(PFS)

  about 2 years

• Overall Survival(OS)

  about 2 years

• Disease Control Rate(DCR)

  about 2 years

Study Arms (1)

anlotinib+TQB2450+nab-paclitaxel+cisplatin

EXPERIMENTAL

Drug: anlotinib+TQB2450+nab-paclitaxel+cisplatin

Interventions

anlotinib+TQB2450+nab-paclitaxel+cisplatin DRUG

Anlotinib: 10mg, po, d1\~14, q3w, until disease progression or unacceptable toxicity. TQB2450: 1200mg, ivgtt, d1, q3w, until disease progression or unacceptable toxicity. nab-paclitaxel: 200mg/㎡, ivgtt, d1, q3w, 6 cycles. cisplatin: 60mg/㎡, ivgtt, d1, q3w, 6 cycles.

anlotinib+TQB2450+nab-paclitaxel+cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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 v1.1. 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: 0-1.
• \. 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.

You may not qualify if:

• \. 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;
• \. Patients who have received VEGFR inhibitors such as sorafenib, sunitinib, or apatinib;
• \. Patients with unhealed wounds or fractures;
• \. Patients with abnormal thyroid function;
• \. Urine protein ≥++ or 24-hour urine protein quantity greater than 1.0g;
• \. Received target focus radiotherapy within 4 weeks prior to the first dose of study therapy;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

Central Study Contacts

Hong Zong, doctor

CONTACT

0086-13523586882; zonghong522@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: March 13, 2023
• First Posted: April 13, 2023
• Study Start: April 10, 2023
• Primary Completion: October 10, 2023
• Study Completion: October 10, 2024
• Last Updated: September 13, 2023

Record last verified: 2023-09

Locations

CN (1)