PD-1 inhibitors with local therapy at different timings in oligometastatic ESCC

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 observational study compares two timings of adding local radiotherapy to systemic PD-1 inhibitor treatment in patients with oligometastatic ESCC. It aims to clarify how sequencing affects disease control, treatment tolerance, and quality of life. Eligible participants have limited metastases, good performance status, and no recent anti-PD-1/PD-L1 therapy. Imaging and biomarker data may be collected, but the protocol notes that comprehensive biopsy or PD-L1 testing is not mandatory. Lead oversight is at Fudan University Shanghai Cancer Center in Shanghai, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. An eastern cooperative oncology group (ECOG) score of 0-1.
2. Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
3. Genuine oligometastasis (without a history of polyme-tastatic disease).
4. A total of four or fewer distant metastases, a maximum of three metastases in a single organ, and a maximum diameter of each metastatic lesion not exceeding 5 cm.
5. Biopsy of a metastatic lesion, PET/CT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.
6. No history of anti-PD-1/PD-L1 therapy. However, the following conditions are also eligible for inclusion: the use of anti-PD1/PD-L1 during induction/neoadjuvant/ concurrent therapy, or the use of anti-PD1/PD-L1 for maintenance therapy but not due to toxicity or disease progression interrupting anti-PD1/PD-L1 treatment, and the interruption has lasted for more than 3 months.
7. Adequate hematological, hepatic, renal, and coagula-tion function. Baseline laboratory tests required to assess eligibility, including ANC ≥ 1.5 × 10\^9/L, PLT ≥ 80 × 10\^9/L, Hb ≥85 g/L, ALB ≥28 g/L, TBIL ≤ 1.5 × ULN, ALT and AST ≤ 3 × ULN, Cr ≤ 1.5 × ULN or CrCl ≥40 mL/min, FEV1 ≥ 1 L. (liver metastases ALT and AST ≤ 5 × ULN, liver or bone metastases AKP ≤ 5 × ULN).(9) Enrolled voluntarily and signed informed consent by the patient himself or his legal representative.

Exclusion Criteria:

1. Pregnant or lactating women.
2. Lung V20 remains over 25%.
3. Confirmed diagnosis or clinical suspicion of esophageal fistula.
4. Recurrence in the irradiated field.
5. Active infection requiring systemic therapy.
6. Active autoimmune disease requiring systemic treat-ment in the past 2 years.
7. Immunodeficiency diagnosis, systemic steroid therapy, or any immunosuppressive treatment within 7 days before the first study treatment dose.
8. Patients with a known history of grade 3 or higher adverse events, which are unsuitable for Anti-PD-1 therapy or adverse events that have not recovered to ≤CTCAE grade 1 (except alopecia).
9. Uncontrolled pleural effusion, pericardial effusion, or pelvic ascites requiring repeated drainage.
10. Unable or rejection to receive Anti-PD-1 therapy or unable to comply with study requirements or follow-up schedule.(11) Inability to provide informed consent.

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Where it's running

• Fudan University Shanghai cancer center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Guangmin Mao
• Email: melly01@256.com
• Phone: 86-13732284526

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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.