SBRT Sequential Surufatinib Combined With Immunotherapy for Biliary Tract Carcinoma

NCT06199882 | Suspended Phase 2

• 1 other identifier: 2023-383
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open, single-center Phase II clinical study to observe and evaluate the efficacy and safety of SBRT sequential surufatinib combined with immunotherapy in patients with locally unresectable or recurrent biliary tract cancer after the first surgery.

Conditions

Biliary Tract Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  The proportion of subjects in the analyzed population who developed complete response (CR) and partial response (PR) according to RECIST (version 1.1) criteria.

  up to 12 months

Secondary Outcomes (4)

• Progression-free survival (PFS)

  up to 12 months

• Local control rate (LCR)

  up to 12 months

• Overall survival (OS)

  up to 36 months

• Incidence of adverse events （AE）

  Until the last medication for 30 days (±7 days) or before the start of other anti-tumor therapy (whichever occurs first)

Study Arms (1)

SBRT Sequential Surufatinib Combined With Immunotherapy

EXPERIMENTAL

SBRT : Bioequivalent total dose \> 75Gy, completed within 2 weeks (once daily, 5 times a week). Drug treatment (every 3 weeks is a treatment cycle) : 1\) Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time, intravenous drip on the first day of each cycle.

Drug: SBRT Sequential Surufatinib Combined With Immunotherapy

Interventions

SBRT Sequential Surufatinib Combined With Immunotherapy DRUG

1. SBRT : Bioequivalent total dose \> 75Gy, completed within 2 weeks (once daily, 5 times a week). 2. Drug treatment (every 3 weeks is a treatment cycle) : 1\) Surufatinib: 200 mg, po, qd, taken continuously; 2) Carrelizumab: 200 mg/ time, intravenous drip on the first day of each cycle.

Also known as: SBRT--Surufatinib+Carrelizumab

SBRT Sequential Surufatinib Combined With Immunotherapy

Eligibility Criteria

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

You may qualify if:

• To be enrolled in this study, patients must meet all of the following criteria:
• The subjects voluntarily joined the study and signed the informed consent, with good compliance and follow-up;
• Age 18-75 years old (including 18 and 75 years old), gender is not limited;
• Patients with unresectable or untreated recurrent BTC confirmed by histopathology or cytology (including intrahepatic, extrahepatic, and gallbladder cancers);
• Have not received any anti-tumor therapy before;
• Have at least one measurable lesion (according to RECIST 1.1 standards); Magnetic resonance imaging (MRI) enhancement or computed tomography (CT) enhancement were used to accurately measure the diameter ≥10mm, and conventional CT scan was used to measure the diameter at least 20mm.
• Normal liver volume (total liver volume minus tumor GTV volume) exceeds 1000cc;
• The maximum diameter of the tumor is less than 10cm, allowing up to 3 satellite foci. Satellite foci were defined as being less than 2cm and within 1cm of the gross tumor.
• No serious organic diseases of heart, lung, brain and other organs;
• The main organs and bone marrow functions are basically normal:
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• Blood routine: white blood cells ≥ 4.0 x 10\^9/L, neutrophils ≥ 1.5 x 10\^9/L, platelets ≥ 80 x 10\^9/L, hemoglobin ≥ 90g/L;
• International Standardized ratio (INR) and activated partial thromboplastin time (APTT) ≤1.5× upper limit of normal (ULN);
• Liver function: serum total bilirubin ≤ 1.5 x ULN, ALT/AST ≤ 3 x ULN, serum total bilirubin ≤ 1.5 x ULN after internal/external drainage of obstructive jaundice;
• Renal function: serum creatinine ≤ 1.5x ULN, creatinine clearance (CCr) ≥ 50mL/min;

You may not qualify if:

• The study proposal shall be excluded if any of the following criteria are met:
• Have received any antitumor therapy in the past (except simple surgical resection);
• The tumor directly invades the stomach, small intestine or colon;
• The maximum diameter of the lesion exceeds 10cm, or the satellite lesion does not meet the above definition criteria;
• Have had other malignancies within the past 5 years, except basal cell or squamous cell carcinoma of the skin after radical surgery, or carcinoma in situ of the cervix;
• There are extra-hepatic metastases (excluding local regional lymph nodes);
• Normal liver volume is less than 1000cc;
• The patient currently has hypertension that cannot be controlled by drugs, as follows: systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg;
• Urine routine indicated urinary protein ≥2+, and 24-hour urinary protein volume \>1.0g;
• Patients whose tumors are judged by the investigators to be at high risk of invading vital blood vessels and causing fatal massive bleeding during the follow-up study;
• Patients with evidence or history of significant bleeding tendency within 3 months prior to enrollment (bleeding within 3 months\> 30 mL, hematemesis, stool, stool blood), hemoptysis (within 4 weeks \> 5 mL fresh blood); Patients with a history of hereditary or acquired bleeding or coagulation disorders have clinically significant bleeding symptoms or definite bleeding tendencies within 3 months, such as gastrointestinal bleeding and hemorrhagic gastric ulcers;
• Clinically significant cardiovascular disease, including but not limited to acute myocardial infarction, severe/unstable angina pectoris, or coronary artery bypass grafting within 6 months prior to enrollment; New York Heart Association (NYHA) Grades for Congestive Heart Failure \>Level 2; Ventricular arrhythmias requiring medical treatment; Electrocardiogram (ECG) showed QTC interval ≥480 ms.
• Active or uncontrolled severe infection (≥CTCAE grade 2 infection);
• Women who are pregnant (positive pregnancy test before medication) or breastfeeding;
• Any other medical condition, clinically significant metabolic abnormality, physical abnormality or laboratory abnormality, in which, in the investigator's judgment, there is reason to suspect that the patient has a medical condition or condition that is not suitable for the use of the investigational drug (such as having seizures and requiring treatment), or that would affect the interpretation of the study results or place the patient at high risk;

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Liu luying

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

Immunotherapy

Intervention Hierarchy (Ancestors)

Immunomodulation; Biological Therapy; Therapeutics

Study Officials

• Luying Liu, M.D.

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

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: MD

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: January 10, 2024
• Study Start: February 1, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 15, 2024

Record last verified: 2024-10

Locations

CN (1)