Neoadjuvant Anti-PD-1 Plus Chemotherapy in Locally Advanced Resectable Esophageal Squamous Cell Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorShanghai Zhongshan Hospital
About this trial
The purpose of this study is to evaluate the outcomes and identify predictors of neoadjuvant anti-PD-1 plus chemotherapy in locally advanced resectable esophageal squamous cell carcinoma (ESCC). In this single-center cohort study, we are aiming to (1) evaluate the therapeutic efficacy and survival benefits on patients with locally advanced resectable ESCC (cT3-4aN0-1M0); (2) evaluate the value of genomic indicators including MMR alternation status in predicting therapeutic responses and prognosis; (3) evaluate the value of transcriptomic indicators including B cell lineage features in predicting therapeutic responses and prognosis; (4) evaluate the value of microbial and metabolite indicators in predicting therapeutic responses and prognosis. Whole exome sequencing, RNA sequencing, 16S rRNA sequencing and Liquid Chromatography with tandem mass spectrometry (LC-MS-MS) of samples of patients to neoadjuvant chemoimmunotherapy before and after treatment are performed to explore the mechanisms of drug resistance and identification of predictive and prognosis biomarkers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically-confirmed squamous cell carcinoma of the esophagus;
Tumors of the esophagus are located in the thoracic cavity;
Pre-treatment stage as cT3-4aN0-1M0 (AJCC/UICC 7th Edition) (In case of stage cT4a, curative resectability has to be explicitly verified by the local surgical investigator prior to randomization).
Age is between 18 years and 75 years,
Disqualifiers
Patients with non-squamous cell carcinoma histology;
Patients with advanced inoperable or metastatic esophageal cancer;
Pre-treatment stage as cT1-2N0-1M0 (AJCC/UICC 7th Edition);
Pre-treatment stage as cN2-3 or cT4b(non-curatively-resectable verified by the local surgical investigator, AJCC/UICC 7th Edition);
Trial population
Patients with locally advanced resectable ESCC (cT3-4aN0-1M0)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
neoadjuvant anti-PD-1 plus chemotherapy
DrugPatients will be given preoperative treatment as below once recruited: 1. Chemotherapy is delivered and composed of two cycles of Nab-paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 3 weeks; 2. PD-1 antibody is delivered 200 mg (iv, in 30 minutes) every 3 weeks; 3. After neoadjuvant therapy of 3-4 cycles, esophagectomy is performed. We advise starting 4 cycles of identical chemoimmunotherapy in 6w after surgery.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant Anti-PD-1 Plus Chemotherapy Group1 intervention
Trial outcomes
Primary outcomes
1
Major pathological regression (MPR) rate
The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. MPR was defined as ≤10% residual viable tumor.
Time frame
Up to the date of pathological reports obtained since the date of enrollment, up to 6 monthsSecondary outcomes
1
Pathological response rate(pCR)
The resected specimen following neo-adjuvant treatment are assessed by using standardised work up of the resection specimen in the pathology department and standardised histological criteria for tumour regression grading. PCR was defined as no evidence of vital residual tumor cells.
Time frame
Up to the date of pathological reports obtained since the date of enrollment, up to 6 months2
objective response rate (ORR)
ORR is evaluated by chest, abdominal \& pelvic CT/MRI based on RESIST 1.1. Evaluation will be conducted every 6 weeks during neoadjuvant therapy and every 6 months after surgery.
Time frame
36 months after the last subject participating in3
overall survival (OS)
OS is defined as time interval from recruitment to all-caused death or censoring.
Time frame
36 months after the last subject participating in4
Progression-free survival(PFS)
Disease recurrence is defined as locoregional (esophageal bed or anastomotic or regional lymph nodes) or metastatic (supraclavicular lymph nodes or distant organs).
Time frame
36 months after the last subject participating inSponsors and contacts
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Source ClinicalTrials.gov