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.
This single-arm Phase II study aims to explore the safety and efficacy of concurrent chemoradiotherapy combined with toripalimab and surufatinib in treating LS-SCLC. In this single-arm, Phase II study, patients are planned to receive four cycles of etoposide combined with either cisplatin or carboplatin, along with toripalimab and surufatinib. During chemotherapy, patients will undergo concurrent radiotherapy. Following chemoradiotherapy, consolidation treatment with toripalimab and surufatinib will be administered. Prophylactic cranial irradiation (PCI) is recommended prior to the consolidation therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
47
Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.
Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.
Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.
Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.
PCI is recommended after the completion of chemoradiotherapy.
Patients achieving complete response (CR), partial response (PR), or stable disease (SD) following chemoradiotherapy will receive consolidation therapy. Toripalimab: 240 mg intravenously on day 1, every three weeks. Surufatinib: 200 mg orally on days 1-14, every three weeks.
Sun yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGMedian progression-free survival (PFS)
The length of time from the start of treatment until disease progression or death from any cause, whichever occurs first.
Time frame: 2 years
Median overall survival (OS)
The time from the start of treatment to death from any cause.
Time frame: 2 years
Treatment-related adverse events
The assessment of treatment-related adverse events (AEs), including their type, severity, frequency, and impact on patients.
Time frame: 1 year after treatment
Patient-Reported Outcomes
Patient reported quality of life measured by European organization for Research and Treatment of Cancer (EORTC) Quality of Life Core 30 (QLQ-C30) and QLQ-LC13.
Time frame: 1 year after treatment
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