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Trial Title:
Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors
NCT ID:
NCT05527821
Condition:
Unresectable Advanced Solid Tumors
Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer
Conditions: Official terms:
Neoplasms
Small Cell Lung Carcinoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Surufatinib
Description:
Surufatinib 250mg will be taken orally once daily continuously on a 21-day cycle
Arm group label:
Surufatinib Combined With Sintilimab and SCRT
Intervention type:
Drug
Intervention name:
Sintilimab
Description:
Sintilimab 200mg will be intravenously administered on Day 1 of each cycle
Arm group label:
Surufatinib Combined With Sintilimab and SCRT
Intervention type:
Radiation
Intervention name:
Short course radiotherapy
Description:
5Gy*5F short course radiotherapy will be delivered
Arm group label:
Surufatinib Combined With Sintilimab and SCRT
Summary:
An exploratory clinical study of short course radiotherapy combined with surufatinib and
sintilimab in the treatment of relapsed and refractory advanced solid tumors
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age 18-75 years (including 18 and 75 years), both genders;
2. 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;
3. The lesions can be clearly evaluated by imaging;
4. Expected survival ≥ 12 weeks;
5. No serious abnormalities of blood system, heart, lung, liver, kidney function or
immune deficiency;
6. Laboratory tests (without blood transfusion within 14 days) shall meet the following
requirements:
7. If a fertile man or woman is willing to use contraception during the trial;
8. Physical status score ECOG 0-1;
9. Patients or their family members agreed to participate in the study and signed the
informed consent form;
Exclusion Criteria:
1. 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.);
2. Women who are breast feeding, pregnant or preparing to become pregnant;
3. Corticosteroids (dose equivalent to prednisone & GT; 10 mg/ day) or other
immunosuppressive therapy;
4. 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);
5. 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);
6. 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;
7. Allergic constitution and multiple drug allergy;
8. Patients judged by other investigators to be unable to tolerate chemotherapy or not
suitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Union hospital
Address:
City:
Wuhan
Zip:
430000
Country:
China
Start date:
September 30, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05527821
