Clinical trial · Interventional
Study of Surufatinib Combined With Sintilimab and SCRT in Advanced Solid Tumors
An Exploratory Clinical Study of Short Course Radiotherapy Combined With Surufatinib and Sintilimab in the Treatment of Relapsed and Refractory Advanced Solid Tumors
NCT05527821CI-TRIAL-00060696unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
An exploratory clinical study of short course radiotherapy combined with surufatinib and sintilimab in the treatment of relapsed and refractory advanced solid tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Tumors, Gastric Cancer, Small Cell Lung Cancer | — | UNRESOLVED | — |
| Unresectable Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Short course radiotherapy | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
| Surufatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Surufatinib Combined With Sintilimab and SCRT
- interventionNames
- Drug: Surufatinib
- Drug: Sintilimab
- Radiation: Short course radiotherapy
Primary outcomes (1)
- measure
- Progression-free Survival (PFS)
- timeFrame
- From Baseline to primary completion date, about 24 months
- description
- A duration from the date of initial treatment to disease progression or death of any cause
Secondary outcomes (4)
- measure
- Objective response rate (ORR)
- timeFrame
- From Baseline to primary completion date, about 24 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.