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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Nimotuzumab with chemoradiotherapy
Combination productRadiotherapy,40-50.4Gy/20-28f. Nimotuzumab 400mg,ivgtt,W2d. Chemotherapy, S-1,40-60mg/m2, on BSA, orally twice daily on radiotherapy days.
Treatment groups
55 Participants
are divided into 1 treatment groupGroup A: Nimotuzumab concurrent with chemordiotherapy followed by surgeryExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
R0 resection rate
Minimal distance tumor/circumferential resection margin (CRM) \> 1 mm.
Time frame
4 months after initiation of induction chemoimmunotherapySecondary outcomes
1
Pathological complete response
the complete remission of all viable cancer cells in any of the specimens from surgery, including the primary site and lymph nodes
Time frame
4 months after initiation of induction chemoimmunotherapy2
Event-free survival
the time from start of chemoradiotherapy to 1 month after chemoradiotherapy
Time frame
1 month after chemoradiotherapy3
Postoperative complications
Time frame
1 month after surgery4
Overall survival
the time from start of induction chemo(immuno)therapy to all-cause death, or the last day of follow-up
Time frame
1 year after all treatmentSponsors and contacts
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Source ClinicalTrials.gov