Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Recruiting now · Phase 2
Conditions studied: Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell Carcinoma
In brief
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.
Key facts
- Study ID
- NCT05978193
- Run by
- Shanghai Chest Hospital
- People needed
- 100
- Starts
- 2023-01-01
- Expected to finish
- 2028-01-01
- Last updated by the study team
- 2026-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥18;
- Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
- ECOG performance status: 0-1 point;
- No prior anti-tumor treatment;
- Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.
You may not qualify if…
- Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
- Patients who are potentially curable with surgery as assessed by investigators;
- Pleural metastasis or malignant pleural effusion, pericardial effusion;
- Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
- High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
- Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
- Unstable cardiac diseases or symptoms;
- History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
- Active autoimmune disease or history of autoimmune disease;
- Conditions of immunodeficiency or active infection requiring systemic therapy;
- Pregnant or breastfeeding;
- Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
Where it is running
- Shanghai Ruijin Hospital — Shanghai, China (enrolling)
- Shanghai Chest Hospital — Shanghai, China (enrolling)
Full record on ClinicalTrials.gov
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