Combining radiotherapy with immunotherapy for advanced esophageal cancer

First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center Trial (SCR-ESCC-01)

This study is testing if adding low-dose and regular radiotherapy to standard immunotherapy and chemotherapy can help people with advanced esophageal cancer live longer without their disease getting worse.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Chest Hospital (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Shanghai and 1 other locations)
• Trial ID: NCT05978193 on ClinicalTrials.gov

What this trial studies

This phase II clinical trial investigates the effectiveness of combining low-dose radiotherapy (LDRT) and conventionally fractionated radiotherapy (CFRT) with first-line immunochemotherapy in patients with metastatic esophageal squamous cell carcinoma (ESCC). Participants will be randomly assigned to receive either a PD-1 inhibitor with chemotherapy or the same treatment plus LDRT and CFRT. The primary goal is to assess the median progression-free survival (PFS) of the two treatment arms. The study aims to explore the potential synergistic effects of combining these therapies to improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic esophageal squamous cell carcinoma and an ECOG performance status of 0-1.

Not a fit: Patients with non-squamous cell esophageal carcinoma or those who are potentially curable with surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance treatment outcomes for patients with metastatic esophageal squamous cell carcinoma.

How similar studies have performed: Other studies have shown promising results with similar combinations of radiotherapy and immunotherapy, suggesting potential for success in this approach.

Eligibility criteria

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).

Where this trial is running

Shanghai and 1 other locations

• Shanghai Ruijin Hospital — Shanghai, China (RECRUITING)
• Shanghai Chest Hospital — Shanghai, China (RECRUITING)

Study contacts

• Principal investigator: Wen Yu, M.D — Shanghai Chest Hospital
• Study coordinator: Wen Yu, M.D

Conditions: Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell Carcinoma, Immunotherapy, low-dose radiotherapy, Esophageal squamous cell carcinoma, Immunoradiotherapy