Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

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.

Eligibility

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, esophageal fistula, or perforation;
6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
7. Unstable cardiac diseases or symptoms;
8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
9. Active autoimmune disease or history of autoimmune disease;
10. Conditions of immunodeficiency or active infection requiring systemic therapy;
11. Pregnant or breastfeeding;
12. 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).

Conditions4

Interventions1

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