A Safety and Efficacy Study of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer

NCT05056116 | Unknown

• 1 other identifier: HMPL-012-SPRING-B101
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A Phase Ⅱ, open-label, single-arm study to assess the safety, tolerability, and efficacy of Surufatinib Combination With Toripalimab in Patients With Recurrent Biliary Tract Cancer.

Conditions

Biliary Tract Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response rate(ORR)

  The number of cases in which tumor size is reduced to PR or CR / the total number of evaluable cases (%). In the event of PR or CR, the subjects should confirm it no less than 4 weeks after the first evaluation. CT/MRI will be performed every 2 cycles of treatment by RECIST 1.1(each cycle is 21 days))

  up to 24 months

Secondary Outcomes (2)

• Progression-free survival (PFS)

  up to 12 months

• Overall survival (OS)

  up to 36 months

Study Arms (1)

Biliary Tract Cancer

EXPERIMENTAL

Surufatinib 250mg/Toripalimab 240mg

Drug: Surufatinib Toripalimab

Interventions

Surufatinib Toripalimab DRUG

Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Toripalimab injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.

Also known as: Surufatinib/JS001

Biliary Tract Cancer

Eligibility Criteria

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

You may qualify if:

• Male and Female aged between 18 and 75 years are eligible; Provision of written Informed Consent Form (ICF) prior to any study specific procedures;
• Advanced (unresectable) or metastatic biliary carcinomas that have been histologically or cytologically confirmed include intrahepatic or extrahepatic carcinoma of the bile duct, carcinoma of the gallbladder, and carcinoma of the ampullary of fatt, and have been histologically confirmed as adenocarcinoma;
• Patients who have previously received disease progression or toxic side effects after first-line systemic chemotherapy are not tolerated;The standard first-line chemotherapy regimen was defined as a two-drug combination regimen of gemcitabine plus cisplatin, gemcitabine plus gio, or capecitabine plus oxaliplatin.Failure of first-line standard chemotherapy was defined as progression of disease during treatment or within 6 months after the last treatment;Or the toxic side effects of the treatment process are intolerable;
• Presence of at least one measurable target lesion for further evaluation according to RECIST criteria;
• Patients who had previously received A VEGF or VEGFR-targeted drug required progression 4 months after the last dose;
• No systemic antitumor therapy in 4 weeks;
• The patient has no evidence of biliary obstruction unless the obstruction is controlled by local treatment or the patient is decompressed by endoscopic or percutaneous stenting, and bilirubin is subsequently reduced to below the upper limit of 1.5x normal (ULN);
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;Predicted survival ≥3 months;
• Screening laboratory values must meet the following criteria (within past 14 days):
• neutrophils ≥1.5×109/L ;
• platelets ≥9g/dL；
• hemoglobin ≥ 9.0 g/dL;
• albumin≥3g/dL；
• total bilirubin ≤ 1.5 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5╳ULN;
• Voluntary enrollment, good compliance, can cooperate with the experiment observation, and signed a written informed consent;

You may not qualify if:

• Prior treatment with Surufatinib,or other antiangiogenic drugs were used within 6 months;
• Prior antitumor therapy with chemotherapy, radical radiation therapy ，biological immunotherapy，targeted therapy within 4 weeks.
• Prior participation in other clinical trials not approved or listed in China within past 4 weeks；
• Prior major surgery within past 4 weeks (diagnostic surgery excluded);
• International standardized ratio (INR) \>1.5 or partially activated prothrombin time (APTT) \>1.5×ULN;
• Clinically significant severe electrolyte abnormality judged by investigator ;
• Hypertension that is not controlled by the drug, and is defined as: SBP≥140 mmHg and/or DBP≥90 mmHg;
• Currently suffering from poorly controlled diabetes (after regular treatment, fasting plasma glucose concentration ≥10mmol/L);
• The patient currently has disease or condition that affects the absorption of the drug, or the patient cannot be administered orally;
• Digestive tract disease such as gastric and duodenal active ulcer, ulcerative colitis or unresected tumor, or other conditions determined by the investigator that may cause gastrointestinal bleeding and perforation;
• Evidence of bleeding tendency or history within 3 months, or thromboembolic event (including a stroke event and/or a transient ischemic attack) occurred within 12 month;
• Cardiovascular disease of significant clinical significance (myocardial infarction, unstable arrhythmia or unstable angina ，Coronary Artery Bypass Grafting within past 6 months,)；
• Had other malignant tumors in the past 5 years (except for basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ that have been effectively controlled);
• Active or uncontrolled severe infection (≥CTCAE2 infection);
• Positive tests for HIV, HCV, HBsAg or HBcAb with positive test for HBV DNA (\>2000IU/ml);

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

surufatinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Renhao Wang, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

• Bin Zhang, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renhao Wang, MD

CONTACT

13605207887; wangrenhao@126.com

Bin Zhang, MD

CONTACT

15252039221; zhangbin@xzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: September 24, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2024
• Last Updated: December 27, 2021

Record last verified: 2021-12

Locations

CN (1)