Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors

NCT05527821 | Unknown Phase 2 DMC

• 1 other identifier: HMPL-012-SPRING-ST101
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors

Conditions

Unresectable Advanced Solid Tumors; Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  A duration from the date of initial treatment to disease progression or death of any cause

  From Baseline to primary completion date, about 24 months

Secondary Outcomes (4)

• Objective response rate (ORR)

  From Baseline to primary completion date, about 24 months

• Disease Control Rate

  From Baseline to primary completion date, about 24 months

• Overall survival (OS)

  From the time of enrollment to death caused by any reason

• The incidence of adverse events

  From Baseline to primary completion date, about 24 months

Study Arms (1)

Surufatinib Combined With Sintilimab and SCRT

EXPERIMENTAL

Drug: Surufatinib; Drug: Sintilimab; Radiation: Short course radiotherapy

Interventions

Surufatinib DRUG

Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle

Surufatinib Combined With Sintilimab and SCRT

Sintilimab DRUG

Sintilimab 200mg will be intravenously administered on Day 1 of each cycle

Surufatinib Combined With Sintilimab and SCRT

Short course radiotherapy RADIATION

5Gy\*5F short course radiotherapy will be delivered

Surufatinib Combined With Sintilimab and SCRT

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 (including 18 and 75 years), both genders;
• Unresectable malignant tumors confirmed by histology or cytology (mainly biliary tract tumors, gastric cancer, small cell lung cancer, and other tumor types were included as appropriate), which failed at least after first-line standard treatment;
• The lesions can be clearly evaluated by imaging;
• Expected survival ≥ 12 weeks;
• No serious abnormalities of blood system, heart, lung, liver, kidney function or immune deficiency;
• Laboratory tests (without blood transfusion within 14 days) shall meet the following requirements:
• If a fertile man or woman is willing to use contraception during the trial;
• Physical status score ECOG 0-1;
• Patients or their family members agreed to participate in the study and signed the informed consent form;

You may not qualify if:

• Previous treatment with anti-VEGF/VEGFR-targeted drugs, such as surufatinib; Or previous treatment with anti-PD-1, anti-PD-L1, or anti-PD-L2 drugs or another stimulatory or synergistic inhibition of T-cell receptors (including but not limited to CTLA-4, OX-40, LAG-3, CD137, etc.);
• Women who are breast feeding, pregnant or preparing to become pregnant;
• Corticosteroids (dose equivalent to prednisone \& GT; 10 mg/ day) or other immunosuppressive therapy;
• Active, known or suspected autoimmune diseases or before 2 years of the history of the disease (in nearly 2 years can be treated as system of vitiligo, psoriasis, hair loss, or graves disease, need only thyroid hormone replacement therapy for hypothyroidism and only need insulin replacement therapy in patients with type 1 diabetes can group);
• Allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; Persons with HIV infection or active hepatitis b or c (active hepatitis b reference: HBV DNA≥1×104 copies /ml or ≥2000IU/ml; Active hepatitis C reference: HCV RNA≥1×103 copies /ml);
• Interstitial lung disease (including past history and current condition), such as interstitial pneumonia, pulmonary fibrosis, or evidence of ILD on baseline chest CT or MRI;
• Allergic constitution and multiple drug allergy;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union hospital

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Stomach Neoplasms; Small Cell Lung Carcinoma

Interventions

surufatinib; sintilimab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

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: Director

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: September 6, 2022
• Study Start: September 30, 2022
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: September 6, 2022

Record last verified: 2022-09

Locations

CN (1)