Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma

Phase 2

Recruiting

• Conditions: Metastatic Esophageal Squamous Cell Carcinoma; Esophageal Cancer; Esophageal Squamous Cell Carcinoma
• Interventions: Radiation: LDRT+CFRT; Drug: Chemotherapy; Drug: Immunotherapy

• Registration Number: NCT05978193
• Lead Sponsor: Shanghai Chest Hospital

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-07
• Last Update Posted: 2023-08-07
• Primary Completion: 2026-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B	Chemotherapy	PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
Arm A	Immunotherapy	PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
Arm B	Immunotherapy	PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
Arm A	LDRT+CFRT	PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
Arm A	Chemotherapy	PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)

Primary Outcome Measures

Name	Time	Method
PFS	From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months	Progression-free survival

Secondary Outcome Measures

Name	Time	Method
OS	From date of randomization until the date of death from any cause, assessed up to 36 months	Median overall survival
Incidence of Grade III and higher treatment-related adverse events	1 year

Trial Locations

Locations (2)

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China

Shanghai Chest Hospital; 🇨🇳 Shanghai, China