Actively Recruiting
Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer
Led by Sun Yat-sen University · Updated on 2026-03-03
47
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Based on the preclinical rationale for combining surufatinib with immunotherapy, and the clinical efficacy observed with surufatinib in extensive-stage small cell lung cancer (ES-SCLC), the investigators hypothesize that incorporating surufatinib into the ADRIATIC regimen could further enhance survival in LS-SCLC. To evaluate this approach, the investigators plan to conduct a single-arm Phase II study to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC.
CONDITIONS
Official Title
Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before study procedures
- Aged between 18 and 75 years
- Histologically or cytologically confirmed small cell lung cancer
- Stage I-III limited-stage disease with all lesions included in a single radiotherapy plan
- Stage I-II disease must be inoperable
- Life expectancy of at least 12 weeks
- WHO performance status of 0 or 1
- Postmenopausal or negative pregnancy test within 7 days before treatment
- Female participants must not be breastfeeding
- Women of childbearing potential must use contraception during treatment and for 3 months after last dose
- Male participants sexually active with women of childbearing potential must use contraception during treatment and for 5 months after last dose
- Males with azoospermia are exempt from contraception requirements
- Women of childbearing potential not sexually active must still undergo pregnancy testing
- Adequate organ and bone marrow function including pulmonary function (FEV1 600 mL), neutrophil count 61.5 x 10^9/L, platelet count 100 x 10^9/L, hemoglobin 69.0 g/dL, creatinine clearance 650 mL/min, bilirubin 41.5 x upper limit, AST and ALT 42.5 x upper limit
You will not qualify if you...
- Participation in another clinical trial, except observational studies
- Mixed small cell and non-small cell lung cancer histology
- Extensive-stage small cell lung cancer
- Malignant pleural or pericardial effusion confirmed by pathology
- Central cavitary SCLC with hemoptysis exceeding 50 ml/day
- Use of immunosuppressive drugs within 28 days before first dose of toripalimab, except low-dose corticosteroids and steroids for chemoradiotherapy side effects
- Prior treatment with anti-PD-1 or anti-PD-L1 antibodies
- Major surgery within 4 weeks before study entry
- History of autoimmune diseases within the past 2 years
- History of primary immunodeficiency
- History of organ transplantation requiring immunosuppression
- QTc interval over 470 ms on ECG
- Uncontrolled serious medical conditions such as infections, heart failure, unstable angina, arrhythmias, active ulcers, bleeding disorders, hepatitis C, HIV, high HBV DNA levels, or psychiatric/social issues
- History of tuberculosis
- Received live attenuated vaccine within 30 days before study start
- Another primary cancer within 5 years, except certain treated skin, cervical, breast, or prostate cancers
- Pregnant or breastfeeding women and those not using effective contraception
- Any condition interfering with study drug evaluation
- Investigator's judgment deeming patient unsuitable
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Actively Recruiting
Research Team
B
Bo Qiu, Professor
CONTACT
H
Hui Liu, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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