Timing of local therapy may boost immunotherapy in Hard-to-Treat esophageal cancer
NCT ID NCT07697859
First seen Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time
Summary
This study investigates whether starting local treatments like radiation or surgery early or later alongside immunotherapy improves outcomes for people with esophageal cancer that has spread to a limited number of spots. Participants receive standard chemoimmunotherapy plus local therapy either within the first two cycles or after four cycles. The goal is to find the best sequence to extend life and control the disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PD-1 inhibitor (immunotherapy) combined with local therapy (radiotherapy, surgery, or ablation)
- What this could lead to
- If successful, this could establish the best timing for adding local therapy to immunotherapy, potentially improving survival and quality of life for people with oligometastatic esophageal cancer.
- What could go wrong
- This is a phase III trial, but the optimal timing remains unknown, and results may not apply to all patients. Risks include side effects from both immunotherapy and local treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 354 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Oligometastatic ESCC
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fudan University Shanghai cancer center
RECRUITINGShanghai, Shanghai Municipality, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Which Pre-Surgery combo extends life in esophageal cancer? a virtual trial seeks answers
- Can an AI eye guide surgeons to safer, faster cancer removal?
- Can a triple punch of immunotherapy and chemoradiation wipe out esophageal tumors before surgery?
- Can early tumor response guide smarter cancer treatment?
- Could a smart combo of drugs and radiation help some esophageal cancer patients skip surgery?
- Could more surgery and radiation after immunotherapy keep esophageal cancer at bay?