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New treatment option for Esophageal Squamous Cell Carcinoma (ESCC)
Official title Hypofractionated vs. Conventional Chemoradiotherapy After Induction Chemo-immunotherapy for Unresectable Esophageal Squamous Cell Carcinoma
ClinicalTrials.gov ID: NCT06912074
What this study is testing
What is Induction chemoimmunotherapy?
Induction chemoimmunotherapy is an investigational medicine, being studied as a potential treatment for esophageal squamous cell carcinoma (escc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective, open-label, randomized phase II clinical trial designed to compare the efficacy and toxicity of hypofractionated concurrent chemoradiotherapy versus conventional fractionated concurrent chemoradiotherapy following induction chemoimmunotherapy in patients with unresectable locally advanced esophageal squamous cell carcinoma.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- Male or female aged 18 to 80 years;
- Eligible for oral drug therapy;
- No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
You likely can't join if
- Exclusion Criteria for Induction Treatment:
- Participation in another clinical trial, unless it is an observational (non-treatment) study;
- Use of immunosuppressive drugs within 28 days prior to the first infusion of Toripalimab, excluding physiological doses of intranasal inhaled...
- 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;
See the full eligibility 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...
- 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...
- Signed and dated informed consent must be provided before participation in any study procedures.
- Exclusion Criteria for Induction Treatment:
- Participation in another clinical trial, unless it is an observational (non-treatment) 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...
- 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...
- 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 \ 1.5 times the upper limit of normal (ULN); ALT and AST \>2.5 times ULN.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.