Nimotuzumab Concurrent With Chemoradiotherapy for Esophageal Cancer Patients
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCancer Institute and Hospital, Chinese Academy of Medical Sciences
About this trial
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
Qualifiers
Histologically confirmed esophageal squamous cell carcinoma.
No previous treatment for the esophageal carcinoma.
KPS score ≥70.
NRS-2002 score≥2.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Nimotuzumab with chemoradiotherapy
Treatment groups
55 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov