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Concurrent Chemoradiotherapy Combined With Toripalimab and Surufatinib in the Treatment of Limited-Stage Small Cell Lung Cancer

NCT06719700 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47

Last updated 2026-03-03

No results posted yet for this study

Summary

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

  • Toripalimab
  • Surufatinib
  • Chemoradiotherapy
  • Limited-stage Small Cell Lung Cancer (LS-SCLC)

Interventions

DRUG

Chemotherapy

Etoposide combined with cisplatin or carboplatin, administered every three weeks for a total of four cycles.

DRUG

Immunotherapy

Toripalimab was administered concurrently with chemotherapy, every three weeks for four cycles.

DRUG

Angio-immuno kinase inhibitor

Oral surufatinib 200 mg once daily (q.d.), given on days 1-14 of each chemotherapy cycle.

RADIATION

radiotherapy

Thoracic radiotherapy will begin no later than the start of the third chemotherapy cycle.

RADIATION

Prophylactic Cranial Irradiation

PCI is recommended after the completion of chemoradiotherapy.

DRUG

Consolidation Therapy with Toripalimab and Surufatinib

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.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Hui Liu, Professor · Sun yat-sen universtiy cancer center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2028-11-29
Completion
2028-11-29

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06719700 on ClinicalTrials.gov