NCT07697859Recruiting
PD-1 Inhibitors Combined With Local Therapy at Different Timings in Oligometastatic ESCC
A Phase III Randomized Controlled Study Investigating the Combination of PD-1 Inhibitors With Local Therapy Administered at Distinct Treatment Timings Among Patients With Oligometastatic Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
Although immunotherapy combined with chemotherapy has become the first-line standard regimen for advanced esophageal squamous cell carcinoma (ESCC) and improved clinical outcomes in advanced patients, the prognosis of patients with esophageal cancer remains unsatisfactory, with a 5-year overall survival rate below 20%. As an effective modality for local disease control, local radiotherapy has no established optimal sequencing schedule when combined with systemic therapy. The timing of radiotherapy intervention may directly affect treatment efficacy, treatment tolerance and quality of life of patients. Several studies have explored the impact of radiotherapy timing in oligometastatic ESCC, yet substantial limitations persist in current evidence, resulting in a lack of unified guideline recommendations and wide heterogeneity in clinical practice. Most existing investigations are retrospective or small-sample prospective studies with high heterogeneity in study design, patient population selection and treatment regimens, yielding inconsistent conclusions that cannot support consistent clinical consensus. To clarify the impact of radiotherapy timing on clinical efficacy in oligometastatic esophageal cancer, the investigator designed the present clinical trial. This study aims to compare the efficacy and safety of concurrent radiotherapy versus sequential radiotherapy on the basis of immunochemotherapy among patients with oligometastatic ESCC, so as to fill the evidence gap in existing research.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 354 (estimated)
- First submitted
- 2 Jul 2026
- Start date
- 15 Jul 2026
- Primary completion date
- 15 Jul 2029
- Lead sponsor
- Fudan University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07697859
What you commit to
- Study type: Observational
- Planned participants: 354
- From 15 Jul 2026 to the primary completion date, 15 Jul 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immunodeficiency diagnosis, systemic steroid therapy, or any immunosuppressive treatment within 7 days before the first study treatment dose.
- 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.
- \-
Other illness
- Confirmed diagnosis or clinical suspicion of esophageal fistula.
- Active infection requiring systemic therapy.
- Active autoimmune disease requiring systemic treat-ment in the past 2 years.
- 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).
Other
- Pregnant or lactating women.
- Lung V20 remains over 25%.
- Recurrence in the irradiated field.
- Uncontrolled pleural effusion, pericardial effusion, or pelvic ascites requiring repeated drainage.
Who the study is looking for
- An eastern cooperative oncology group (ECOG) score of 0-1.
- Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
- Genuine oligometastasis (without a history of polyme-tastatic disease).
- 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.
- Biopsy of a metastatic lesion, PET/CT scan, and PD-L1 CPS (IHC 22C3) are not required but preferred.
- 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.
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.