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

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

Official Title
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An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors

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

Intervention / Treatment
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* Drug: Surufatinib
* Drug: Sintilimab
* Radiation: Short course radiotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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; Patients judged by other investigators to be unable to tolerate chemotherapy or not suitable for inclusion.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Surufatinib Combined With Sintilimab and SCRT<br> | Drug: Surufatinib<br>* Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle<br>Drug: Sintilimab<br>* Sintilimab 200mg will be intravenously administered on Day 1 of each cycle<br>Radiation: Short course radiotherapy<br>* 5Gy*5F short course radiotherapy will be delivered<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | The incidence of confirmed complete response or partial response | From Baseline to primary completion date, about 24 months | 
| Disease Control Rate | The incidence of complete response, partial response and stable disease | From Baseline to primary completion date, about 24 months | 
| Overall survival (OS) | From Baseline to primary completion date, about 24 months | From the time of enrollment to death caused by any reason | 
| The incidence of adverse events | The safety and tolerability of Surufatinib will be evaluated based on adverse events data | From Baseline to primary completion date, about 24 months |