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The purpose of this study is to observe and evaluate the efficacy and safety of SHR-1210 for adjuvant treatment of resectable esophageal squamous cell carcinoma
Full description
Although esophagectomy is still the standard treatment for patients with localized esophageal cancer, the long-term therapeutic effect is not satisfactory.About 50% of patients experienced relapse in the first year after treatment. The 5-year survival rate of esophageal cancer patients treated by surgery is still less than 30%. Although the effect of preoperative treatment is relatively clear, the effect of postoperative treatment, especially postoperative chemotherapy, is still controversial and no consensus has been reached.The basic reason is that the postoperative trauma of esophageal cancer is large, and the patients' tolerance to chemotherapy is poor. The efficacy of immunocheckpoint inhibitors in metastatic ESCC has been recognized.We plan to conduct a phase II multicenter, single arm, open phase II clinical trial to evaluate the efficacy and safety of humanized anti PD-1 monoclonal antibody SHR-1210 in adjuvant treatment of resectable esophageal squamous cell carcinoma.
Enrollment
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Inclusion criteria
Histology confirmed as esophageal squamous cell carcinoma;
The clinical stages are cT1b-T4aN0M0, cT1-T4aN+M0;
The subjects were required to complete preoperative concurrent chemoradiotherapy and complete R0 resection before enrollment;
The shortest time of neoadjuvant therapy was 6 weeks and the longest was 12 weeks;
Postoperative pathology: T1 or above T1, N1 or N1 above, no distant metastasis;
Aged 18-75;
ECOG:0-1;
The main organs function normally, that is, the following criteria are met:
Blood routine examination:
HB≥90g/L; ANC ≥ 1.5 × 109 / L; PLT ≥ 80 × 109 / L;
Biochemical examination:
ALB ≥ 30g / L;b.ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN;c.TBIL ≤ 1.5ULN;d.plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min;
There was no serious concomitant disease with a survival time of less than 5 years;
Voluntary and able to comply with the protocol during the study;
Provide written informed consent before entering the study, and patients have understood that they can withdraw from the study at any time without any loss.
Exclusion criteria
Primary purpose
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42 participants in 1 patient group
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Central trial contact
Feng Wang
Data sourced from clinicaltrials.gov
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