Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carci
SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized
| Condition(s) | Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell Carcinoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC. It begins with a safety run-in phase, followed by a randomized controlled comparison against standard immunochemotherapy. |
| Who can participate | Inclusion Criteria: 1. Age ≥18; 2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology; 3. ECOG performance status: 0-1 point; 4. No prior anti-tumor treatment; 5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators. Exclusion Criteria: 1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer; 2. Patients who are potentially curable with surgery as assessed by investigators; 3. Pleural metastasis or malignant pleural effusion, pericardial effusion; 4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy; 5. High risk of gastrointestinal bleeding, esophagea |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Shanghai Chest Hospital |
| Locations | Shanghai, China; Shanghai, China |
| Start date | 2023-01-01 |
| NCT ID | NCT05978193 |
| Official listing | https://clinicaltrials.gov/study/NCT05978193 |