Combining radiotherapy with immunotherapy for advanced esophageal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: yuzhiwen0827@163.com
• Phone: 021-22200000-3203

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.