NCT06429839 Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
| NCT ID | NCT06429839 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 55 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2025-12-31 |
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 55 participants in total. It began in 2023-03-01 with a primary completion date of 2025-12-31.
⚠ 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
Elderly or malnourished patients diagnosed with locally advanced esophageal squamous cell carcinoma (ESCC) had poor prognosis. Radiotherpy was an important and effective treatment in treating ESCC. The present study is a one-arm trial that seeks to evaluate the efficacy in patients with unresectable ESCC. The study objectives include R0 resection rate, complete pathological response and treatment toxicity, etc. Nimotuzumab is a recombinant humanized monoclonal antibody against EGFR. Its efficacy and safety in patients with esophageal cancer have been confirmed by many studies. The current prospective phase II study aimed to evaluate the efficacy and safety of a combination regimen comprising chemotherapy with nimotuzumab with a dose of 800mg per week and S-1 and concurrent radiotherapy for patients who are elderly or malnourished.
Eligibility Criteria
Inclusion Criteria: * Histologically confirmed esophageal squamous cell carcinoma. * No previous treatment for the esophageal carcinoma. * KPS score ≥70. * NRS-2002 score≥2. * Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL; Exclusion Criteria: * Previous treatment of the esophageal cancer with surgery, radiation, or chemotherapy. * Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); * At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites * There are active infections, such as active tuberculosis and hepatitis * There are contraindications to targeted therapy.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06429839 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Esophageal Cancer. 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 NCT06429839 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 NCT06429839 currently recruiting?
Yes, NCT06429839 is actively recruiting participants. Contact the research team at beryl_wx2000@163.com for enrollment information.
Where is the NCT06429839 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06429839 clinical trial?
NCT06429839 is sponsored by Cancer Institute and Hospital, Chinese Academy of Medical Sciences. The trial plans to enroll 55 participants.
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