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

Primary Purpose

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

Status

Not yet recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Surufatinib

Sintilimab

Short course radiotherapy

About this trial

This is an interventional treatment trial for Unresectable Advanced Solid Tumors

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Union hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Surufatinib Combined With Sintilimab and SCRT

Arm Description

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)

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

Secondary Outcome Measures

Objective response rate (ORR)

The incidence of confirmed complete response or partial response

Disease Control Rate

The incidence of complete response, partial response and stable disease

Overall survival (OS)

From Baseline to primary completion date, about 24 months

The incidence of adverse events

The safety and tolerability of Surufatinib will be evaluated based on adverse events data

Full Information

NCT ID

NCT05527821

First Posted

September 1, 2022

Last Updated

September 1, 2022

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT05527821

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 30, 2022 (Anticipated)

Primary Completion Date

September 30, 2024 (Anticipated)

Study Completion Date

September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Surufatinib Combined With Sintilimab and SCRT

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Surufatinib

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Sintilimab

Intervention Description

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

Intervention Type

Radiation

Intervention Name(s)

Short course radiotherapy

Intervention Description

5Gy*5F short course radiotherapy will be delivered

Primary Outcome Measure Information:

Title

Progression-free Survival (PFS)

Description

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

Time Frame

From Baseline to primary completion date, about 24 months

Secondary Outcome Measure Information:

Title

Objective response rate (ORR)

Description

The incidence of confirmed complete response or partial response

Time Frame

From Baseline to primary completion date, about 24 months

Title

Disease Control Rate

Description

The incidence of complete response, partial response and stable disease

Time Frame

From Baseline to primary completion date, about 24 months

Title

Overall survival (OS)

Description

From Baseline to primary completion date, about 24 months

Time Frame

From the time of enrollment to death caused by any reason

Title

The incidence of adverse events

Description

The safety and tolerability of Surufatinib will be evaluated based on adverse events data

Time Frame

From Baseline to primary completion date, about 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Union hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430000

Country

China

12. IPD Sharing Statement

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

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