To purpose of this study is to access the safety and efficacy of neoadjuvant Immunotherapy (PD-1 / PD-L1) combined with chemotherapy for locally advanced thoracic esophageal squamous cellcarcinoma.
Each patient will complete 2 cycles of neoadjuvant therapy and decide whether to operate after evaluating the curative effect if there is no active withdrawal of the subject from the trial or the researcher believes that the subject is not suitable for further trials. The patients after operation and without operation enter the survival follow-up period. If the imaging evaluation is PD after neoadjuvant therapy, the follow-up treatment shall be carried out according to the following principles: the imaging evaluation belongs to the continuous operation that can be operated; If the imaging evaluation was inoperable, radical concurrent radiotherapy and chemotherapy were performed. Postoperative adjuvant therapy shall be performed according to NCCN guidelines. If it is necessary to improve the local control rate, postoperative adjuvant radiotherapy is feasible. At the same time, imaging evaluation was performed until tumor recurrence and metastasis. After tumor recurrence and metastasis, all patients should also enter survival follow-up; In case of drug withdrawal (such as intolerable toxicity) other than recurrence and metastasis during treatment, the treatment is completed, the post-treatment visit is entered, and the survival follow-up is entered after recurrence.
Study Type
OBSERVATIONAL
Enrollment
46
Each patient will complete 2 cycles of neoadjuvant therapy. After evaluating the curative effect, decide whether to operate or not. Patients with and without surgery enter the survival follow-up period.
Tongji hospital
Wuhan, Hubei Provience, China
RECRUITINGPathologic Complete Response
According to the detection of pathological specimens after operation, no malignant tumor cells were detected, so the patient achieved complete pathological remission.
Time frame: 2-5 years
Disease-free Survival
The patient achieved CR (complete remission) and still had no probability of recurrence after treatment in 2-years.
Time frame: 2-5 years
Progression-Free-Survival
The time between the beginning of treatment and the observation of disease progression or death from any cause.
Time frame: 2-5 years
Overall survival
The time from randomization to death from any cause.
Time frame: 2-5 years
Security
The safety of drugs was evaluated from four aspects: adverse events, adverse reactions, serious adverse events and serious adverse reactions.
Time frame: 2-5 years
Objective Response Rate
The proportion of patients whose tumor volume reduced to a predetermined value and could maintain the minimum time limit.
Time frame: 2-5 years
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