Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our study found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is the first-line treatment for ESCC. JS001 is a Chinese anti-PD-1 monoclonal antibody, which has been approved for the treatment of melanoma. This is a prospective, single arm, multicenter, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.
Small cell esophageal carcinoma (SCCE) is a kind of malignant tumor with poor prognosis. Our previous studies found that the mutation spectrum and somatic CNV spectrum of SCCE were similar to those of esophageal squamous cell carcinoma (ESCC). Paclitaxel combined with cisplatin or carboplatin is a common first-line treatment for ESCC. In addition, some studies have shown that PD-1 mAb combined with paclitaxel chemotherapy in esophageal cancer has better efficacy and tolerability than chemotherapy alone. JS001 is a Chinese monoclonal antibody against PD-1 for injection, which has been approved for the treatment of melanoma. This is a prospective, single arm, multicenter, phase II clinical trial of JS001 combined with nab-paclitaxel and cisplatin or carboplatin in the first-line treatment of unresectable or advanced SCCE. Aim to evaluate the safety and efficacy of this regimen in patients with unresectable or advanced SCCE.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
JS001 240mg, ivdrip, d1, Q3w
nab-paclitaxel 220 mg/m2,ivdrip, d1,d8,Q3w
Cisplatin 75mg/m2, ivdrip,d1,Q3w
Carboplatin AUC 5,d1,Q3w
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGObjective response rate (ORR)
Objective response rate (ORR)=CR+PR
Time frame: from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Progression free survival (PFS)
PFS is the time measured from the date of initiation of treatment to the date of progression or death due to any cause, whichever occurs first.
Time frame: from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Overall survival (OS)
Overall survival (OS) is the time calculated from the initiation of treatment to date of death or censored at last follow-up.
Time frame: from the initiation date of first cycle to the date of date of death from any cause, assessed up to 2 years
DCR
Disease control rate (DCR) =CR+PR+SD
Time frame: from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
Six-month progression-free survival rate
Six-month progression-free survival rate is the survival rate calculated at the end of the 6-month follow-up.
Time frame: from the initiation date of first cycle to six months later
One year survival rate
One year progression-free survival rate is the survival rate calculated at the end of the 1-year follow-up.
Time frame: from the initiation date of first cycle to one year later
Severe toxicity
Treatment-related adverse events.
Time frame: from the initiation date of first cycle to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years
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