Overview
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.
Description
In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes to alleviate the symptom of dysphagia. Recent studies have shown that the combination of radiotherapy and immunotherapy may have a synergistic effect on treatment outcomes. The study aims to investigate the benefit of LDRT in combination with conventionally fractionated radiotherapy (CFRT) in improving the outcome of metastatic ESCC concurrently treated with first-line immunochemotherapy. The recruited patients will be randomly (1:1) assigned to receive either PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) (arm B) or in combination with LDRT and CFRT (arm A). The primary endpoint is median progression-free survival (PFS).
Eligibility
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).