A Phase 2 interventional study of PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab） in Esophageal Squamous Cell Carcinomas, sponsored by Shanghai Chest Hospital. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-11-02.
Sponsored by Shanghai Chest Hospital · Phase 2, Interventional, and Treatment
This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of esophageal squamous cell carcinoma patients nonresponding to initial neoadjuvant chemoradiotherapy. The purpose of this study was to evaluate the efficacy and safety of immunotherapy combined with chemotherapy in the adjuvant treatment of esophageal squamous cell carcinoma after surgery.
6,741 studies on the registry are indexed under Carcinoma; 1,163 are open to participants now.
This study's planned enrollment of 54 is above the median of 45 across 5,174 interventional studies indexed under Carcinoma.
Browse Carcinoma studies →Shanghai Chest Hospital is the lead sponsor of 194 studies on the registry; 94 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
PF regimen (cis-platinum of 75mg/m2/d, d1; 5-fluorouracil of 600mg/m2d1-4) combined with PD-1 inhibitors（pembrolizumab，200mg d1） every 3 weeks for 4 cycles followed by PD-1 inhibitors（pembrolizumab，200mg d1）every 3 weeks up to 2 years in a standard manner.
Drug: PF regimen (cis-platinum ; 5-fluorouracil ) combined with PD-1 inhibitors（pembrolizumab）
immunotherapy:PD-1 inhibitor chemotherapy:5-Fu and DDP
Disease-free Survival (DFS)
Disease-free survival is defined as the time between date of surgery and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events.
Time frame: up to approximately 46 months
Overall survival (OS)
Overall survival is defined as the time from date of surgery to date of death from any cause. For subjects that are alive, their survival time was censored at the date of last contact date (or "last known alive date").
Time frame: up to approximately 46 months
Overall Survival Rate
Overall survival rate is defined as the percentage of participants who are alive at 1, 2 and 3 years following surgery
Time frame: From date of surgery to 1, 2 and 3 years later
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shanghai Chest Hospital