NCT07559045 Induction Chemo-Immunotherapy + Radiotherapy vs Concurrent Chemoradiotherapy for Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma
| NCT ID | NCT07559045 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital of Zunyi Medical University |
| Condition | Esophageal Squamous Cell Carcinoma (ESCC) |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 92 participants in total. It began in 2026-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a prospective, randomized, phase II clinical study in patients with unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC). Eligible patients will be randomly assigned in a 1:1 ratio to two treatment groups. The experimental group will receive 3 cycles of induction therapy with PD-1 antibody plus chemotherapy, followed by radiotherapy, and then maintenance therapy with PD-1 antibody monotherapy. The control group will receive concurrent chemoradiotherapy, followed by maintenance therapy with PD-1 antibody monotherapy. The primary endpoints are the complete response (CR) rate at 3 months after radiotherapy (assessed by investigators) and the 1-year progression-free survival (PFS) rate. Secondary endpoints include overall survival (OS), progression-free survival (PFS), duration of response, objective response rate (ORR), local-regional recurrence-free survival (LRFS), distant metastasis-free survival (DMFS), quality of life, and safety profile.
Eligibility Criteria
Inclusion Criteria: * Histologically or cytologically confirmed unresectable stage III-IVA esophageal squamous cell carcinoma (ESCC) * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Adequate organ function (bone marrow, liver, renal, cardiac) within 2 weeks prior to randomization * Measurable or evaluable disease per RECIST 1.1 * Willing to provide written informed consent Exclusion Criteria: * Previous radiotherapy to the chest or previous systemic chemotherapy for ESCC * History of other malignancies within the last 5 years (except cured basal cell carcinoma or cervical carcinoma in situ) * Severe comorbidities (uncontrolled hypertension, NYHA class III-IV heart failure, active infection, etc.) * Known hypersensitivity to any study drugs (paclitaxel, cisplatin/carboplatin, PD-1 antibody) * Pregnant or lactating women * Participation in another clinical trial within 30 days prior to randomization
Contact & Investigator
Lei Zhou, Master
PRINCIPAL INVESTIGATOR
The Second Affiliated Hospital of Zunyi Medical University
Frequently Asked Questions
Who can join the NCT07559045 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma (ESCC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07559045 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07559045 currently recruiting?
Yes, NCT07559045 is actively recruiting participants. Contact the research team at jsdxzl@126.com for enrollment information.
Where is the NCT07559045 trial being conducted?
This trial is being conducted at Zunyi, China.
Who is sponsoring the NCT07559045 clinical trial?
NCT07559045 is sponsored by Second Affiliated Hospital of Zunyi Medical University. The principal investigator is Lei Zhou, Master at The Second Affiliated Hospital of Zunyi Medical University. The trial plans to enroll 92 participants.