Smart scan may personalize esophageal cancer therapy
NCT ID NCT07385664
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase II trial tests whether a special PET scan (FAPI-PET/CT) can help doctors choose the best treatment for people with resectable esophageal cancer. After two cycles of chemoimmunotherapy, the scan results will guide whether patients continue with more chemoimmunotherapy or switch to chemoradiation. The study aims to improve the chance of a complete response (no cancer left after treatment) and involves 66 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemoimmunotherapy and concurrent chemoradiotherapy
- What this could lead to
- If successful, this could lead to a more personalized treatment approach for esophageal cancer, potentially improving response rates and reducing unnecessary side effects.
- What could go wrong
- This is an early phase II trial with only 66 participants, so results may not apply to everyone. The approach is complex and may not improve outcomes over standard care.
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.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 66 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
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.
- Ages
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18 to 75 years
- 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: * Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed. * Age between 18 and 75 years. * Eastern Cooperative Oncology Group (ECOG) performance status score 0-1. * Histologically confirmed esophageal squamous cell carcinoma. * T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET/CT. All lesions, including tumor and lymph nodes, were required to be resectable. * Tumors with strong FAPI uptake on baseline PET/CT scan should have a maximum standardized uptake value (SUVmax) ≥5.0. * Subjects were required to provide preoperative paraffin blocks or white slides of tumor tissue, or freshly collected samples, including at least 3 unstained FFPE pathological slides. * Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose. If urine testing could not confirm the negative result, serum testing was required. Participants who had sex with an unsterilized male partner were required to use an effective contraceptive method from the time of screening and to agree to continue using a contraceptive method for 120 days after the last dose. Discontinuation of contraception after 120 days was discussed with the investigator. * Unsterilized male subjects who have sex with a female partner of childbearing potential are required to use effective contraception from the time of screening until 120 days after the last dose; Discontinuation of contraception after 120 days is also discussed with the investigator. * Laboratory tests must meet the following criteria: Absolute neutrophil count (ANC) ≥ 1500 /µL Platelet count ≥ 100,000/µL Total bilirubin ≤ 2.5 times the upper limit of normal Creatinine clearance (calculated by the following formula) ≥ 60 mL/ minute AST/ALT ≤ 1.5 times the upper limit of normal The modified Cockcroft-Gault equation was used to estimate creatinine clearance (Clcr) : \*\* For serum creatinine concentration (Sr Cr) expressed in mg/dL: Clcr (mL/min) = (140-age) × actual weight (kg)/(72 × Sr Cr(mg/dL)) Results for women were calculated using 85% of the Clcr values for men. Exclusion Criteria: * A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion. * Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc. * Patients with a documented history of severe allergic reactions to sintilimab. * Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements. * Previous radiotherapy administered to the chest or abdomen. * Patients who have received treatments involving platinum agents, taxanes, 5-FU drugs or PD-1 inhibitors. * T4 stage tumors exhibiting definite invasion into the spine, heart, major blood vessels or tracheobronchial tree. * Patients with confirmed cervical or supraclavicular lymph node metastasis or other metastatic lymph nodes that cannot be included in the radiotherapy field nor removed during esophagectomy. * Patients diagnosed with distant metastases through PET/CT scans or other examinations indicating liver, lung or bone metastases. * Individuals suffering from significant uncontrolled cardiovascular diseases (such as heart failure), severe coronary artery disease or recent myocardial infarction; also includes those with serious conditions affecting liver or kidney function (e.g., renal insufficiency or liver cirrhosis). * History of severe central nervous system disorders or mental health issues that may impact treatment compliance and study monitoring. * Individuals presenting severe surgical contraindications that render them unable to tolerate surgery.
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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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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a drug combo stop esophageal cancer from returning after surgery?
- Experimental drug put to the test against Hard-to-Treat GI cancers
- Can a drug combo shrink esophageal tumors before surgery?
- Two-Drug combo targets esophageal cancer that outsmarted immunotherapy
- Can a Triple-Drug combo shrink esophageal tumors before surgery?