New radiation schedule tested to improve esophageal cancer treatment
NCT ID NCT06912074
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether a shorter, more intense course of radiation (hypofractionated) is safer and more effective than the standard longer course for people with advanced esophageal cancer that cannot be surgically removed. All participants first receive two cycles of chemo-immunotherapy (albumin-bound paclitaxel, cisplatin, and toripalimab). Then they are randomly assigned to one of the two radiation schedules, both given with chemotherapy. The study will track cancer progression, survival, and side effects over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- albumin-bound paclitaxel, cisplatin, toripalimab, and radiation therapy
- What this could lead to
- If successful, this could identify a more effective radiation schedule that improves cancer control and reduces side effects for people with advanced esophageal cancer.
- What could go wrong
- This is an early phase 2 trial with only 134 participants, so results may not apply to everyone. The treatments have significant side effects, and the new schedule may not be better than the standard one.
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 134 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Apr 2029
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 80 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: * Pathologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma; * Evaluated as unresectable locally advanced esophageal squamous cell carcinoma by endoscopic ultrasound, imaging studies including esophagography, CT of the neck, chest, and upper abdomen, MRI of the neck and chest, whole-body bone scan, or PET/CT, with staging in the range of II-IVB (stage IVB limited to celiac lymph node or supraclavicular lymph node metastasis); * Male or female aged 18 to 80 years; * Eligible for oral drug therapy; * No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy; * Tumor sample requirement: Must provide adequate unstained, archived tumor tissue samples for analysis; * Expected survival ≥12 weeks; * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1; * Postmenopausal women, or women with a negative urine or serum pregnancy test within 14 days before the study drug administration; * Women must not be breastfeeding; * Organ and bone marrow function must meet the following criteria: Forced expiratory volume in 1 second (FEV1) ≥1000 mL; Absolute neutrophil count ≥1.5 × 10\^9/L; Platelets ≥100 × 10\^9/L; Hemoglobin ≥90 g/L; Estimated glomerular filtration rate (eGFR) ≥50 mL/min based on the Cockcroft-Gault formula (Cockcroft and Gault, 1976); Serum bilirubin ≤1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN; * Signed and dated informed consent must be provided before participation in any study procedures. Exclusion Criteria: Exclusion Criteria for Induction Treatment: * Participation in another clinical trial, unless it is an observational (non-interventional) study; * Use of immunosuppressive drugs within 28 days prior to the first infusion of Toripalimab, excluding physiological doses of intranasal inhaled corticosteroids, prednisone ≤10 mg/day, or equivalent systemic corticosteroids; * Prior use of any anti-PD-1 or anti-PD-L1 antibody; * Major surgery within 4 weeks prior to entering the study (excluding vascular access procedures); * A history of autoimmune disease within the past 2 years; * Active or a history of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis); * History of primary immunodeficiency; * History of organ transplantation requiring immunosuppressive treatment; * Uncontrolled complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, active bleeding disorders, including any known HBsAg-positive patients with HBV DNA \>500 IU/ml, hepatitis C, or HIV, or any psychiatric or social conditions that would impair the ability to comply with study requirements or harm the patient's ability to provide written informed consent; * Receipt of a live attenuated vaccine within 30 days prior to study initiation or within 30 days after receiving Toripalimab; * History of another primary malignancy within 5 years prior to the initiation of Toripalimab treatment, excluding adequately treated skin basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the cervix; * Pregnancy, breastfeeding women, or men and women of reproductive potential who are not using effective contraception. Exclusion Criteria for Concurrent Chemoradiotherapy After Induction Treatment: * Development of distant metastasis (excluding celiac lymph node or supraclavicular lymph node metastasis); * Development of local regional progression, with the radiation oncologist assessing that the patient cannot receive definitive chemoradiotherapy due to normal tissue dose limitations; * PS score of 2-4; * Any of the following organ and bone marrow dysfunction criteria: FEV1 \<1000 mL; absolute neutrophil count \<1.5 × 10\^9/L; platelets \<100 × 10\^9/L; hemoglobin \<90 g/L; serum creatinine clearance \<50 mL/min according to the Cockcroft-Gault formula (Cockcroft \& Gault, 1976); serum bilirubin \>1.5 times the upper limit of normal (ULN); ALT and AST \>2.5 times ULN.
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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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Sun yat-sen University Cancer Center
RECRUITINGGuangzhou, Guangdong, 510060, China
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Other studies related to the condition(s) this trial covers.
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- 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?