Clinical trial · Interventional
Chemoradiotherapy With or Without Sintilimab in Limited-stage SCLC
Chemoradiotherapy With or Without Sintilimab in Limited-stage Small Cell Lung Cancer: a Multicenter Prospective Randomized Phase II Trial
NCT04189094CI-TRIAL-00042082unknownPhase 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)
The study is a prospective, multi-center, open-label, randomized, and controlled phase II clinical trial.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Small Cell Lung Cancer Limited Stage | Lung Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cisplatin | Drug | Cisplatin | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| radiotherapy | Radiation | — | UNRESOLVED |
| Sintilimab | Drug | Sintilimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sintilimab + CRT arm
- description
- Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions). After PCI, Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
- interventionNames
- Drug: Sintilimab
- Drug: Etoposide
- Drug: Cisplatin
- Radiation: radiotherapy
- type
- ACTIVE_COMPARATOR
- label
- CRT arm
- description
- Patients with limited-stage SCLC receive etoposide and cisplatin (carboplatin) for 2 cycles and then receive thoracic radiotherapy (45 Gy/30 fractions) with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histologically/cytologically confirmed diagnosis of SCLC. 2. Radiologically (including brain CT/MRI, chest and abdomen contrasted CT and bone scintigraphy. PET/CT is recommended) confirmed limited-stage. 3. Patients should be ≥ 18 years old. 4. ECOG performance status of 0-1 (Karnofsky performance status ≥ 80). 5. With adequate cardiac, pulmonary, bone marrow, hepatic and renal function. 6. With weight loss no more than 10% within 6 months before diagnosis. 7. Informed consent must be signed. Exclusion Criteria: 1. Histology confirmed the mixed NSCLC components; 2. Other primary malignant tumors appeared within 5 years before the first administration of the study drug, except for locally curable malignant tumors after radical treatment (such as basal or squamous cell skin cancer, superficial bladder cancer or prostate, cervical or breast carcinoma in situ, etc.); 3. Any disease or condition contraindicated by radiotherapy or chemotherapy; 4. Malignant pleural effusion and pericardial effusion; 5. Pregnant and lactating women; 6. History of idiopathic pulmonary fibrosis (IPF), including pneumonia and organic pneumonia; 7. Received live vaccination within 28 days before the first administration of the study drug; 8. 28 days prior to the first administration of the study drug, he participated in any other drug clinical trials or is undergoing other clinical trials. 9. Have received any antibody / drug (including PD-1, PDL1, CTLA4, tim3, Lag3, etc.) targeting T-cell co regulatory protein (immunocheckpoint). 10. The investigator believes that the subject's complications or other circumstances may affect the compliance with the protocol or may not be suitable for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.