Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell
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ClinicalTrials.gov Identifier: NCT06006650 |
Recruitment Status :
Recruiting
First Posted : August 23, 2023
Last Update Posted : August 23, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | August 17, 2023 | ||||||||
First Posted Date ICMJE | August 23, 2023 | ||||||||
Last Update Posted Date | August 23, 2023 | ||||||||
Actual Study Start Date ICMJE | August 1, 2022 | ||||||||
Estimated Primary Completion Date | December 31, 2031 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Pathologic complete response rate (pCR) [ Time Frame: up to 4 months ] Pathologic complete response rate (pCR)
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Neoadjuvant Therapy for Stage II-IVA Resectable Esophageal Squamous Cell | ||||||||
Official Title ICMJE | Pembrolizumab Plus Albumin Paclitaxel or 5-fluorouracil and Cisplatin Versus 5-fluorouracil and Cisplatin in Neoadjuvant Therapy for Resectable Esophageal Squamous Cell Carcinoma: a Prospective, Randomized Controlled Trial Study | ||||||||
Brief Summary | The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed. | ||||||||
Detailed Description | The aim of this study was to investigate the efficacy and safety of pembrolizumab combined with albumin paclitaxel and cisplatin versus albumin paclitaxel and cisplatin or 5-fluorouracil and cisplatin in neoadjuvant therapy for stage II-IVa resectable esophageal squamous cell carcinoma. The study plans to enroll 114 eligible patients who will be randomly assigned in a 1:1:1 ratio to receive 3 cycles of neoadjuvant immunochemotherapy (pembrolizumab plus albumin paclitaxel and cisplatin;Pembrolizumab plus 5-fluorouracil and cisplatin) or chemotherapy alone (5-fluorouracil and cisplatin), followed by surgery 3 weeks later, followed by 16 cycles of adjuvant immunotherapy (pembrolizumab).Patients were followed up for efficacy and safety during treatment.Tumor evaluation will be performed at screening, after neoadjuvant therapy, before surgery, and after adjuvant therapy until objective disease progression is confirmed. Study Endpoints Primary Endpoints PCR: This was assessed by examining the postoperative pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes. Safety: Adverse reactions during neoadjuvant therapy were recorded following CTCAE version 5.0 guidelines. Perioperative complications were assessed using the Clavien-Dindo classification. Grade I complications included any deviation from the normal postoperative recovery process without requiring medical, surgical, endoscopic, or radiological intervention. Acceptable medical management included antiemetics, antipyretics, analgesics, diuretics, electrolytes, and physical therapy. Bedside open incisional infections were included under this category. Grade II complications were those that required medications beyond those used for treating Grade 1 complications, including blood transfusions and total parenteral nutrition. Grade III complications were those that required surgical, endoscopic, or radiological intervention. Grade IV complications were those considered life-threatening and requiring mid-term care or admission to an intensive care unit (including central nervous system complications, such as cerebral hemorrhage, ischemic stroke, and subarachnoid hemorrhage, and excluding transient ischemic attacks). Grade V complications included patient deaths. Secondary Endpoints 1) Major pathological response (MPR) refers to the proportion of residual tumor cells in the primary tumor and lymph nodes in the postoperative pathological tissue being <10%, or the primary tumor completely disappearing, and the number of positive lymph nodes being ≤1. 2) R0 resection rate: R0 resection was defined as achieving negative upper and lower resection margins. 3) RECIST Criteria Assessment: Complete response (CR): complete response of target lesions; PR: >30% regression of target lesions; Non-CR/Non-PD: target lesions did not completely disappear and did not increase by >20%, or other new lesions appeared in the body; Stable disease (SD): target lesions were reduced or increased by <20%; Progressive disease (PD): target lesions had increased by >20%. Statistical Methods The sample size was determined using Simon's two-stage design. With a minimum expected pCR of 20% and an expected pCR of 40%, a Type I error (α) of 0.05, and a Type II error of 80%, a sample size of 34 was calculated. In the first stage, 17 patients were enrolled. The study was carefully monitored to limit the number of pCR cases to three or below, and any increase in the risk of surgery and mortality due to the treatment regimen would have led to its discontinuation. All continuous variables were presented as frequencies. Statistical significance was set at P <0.05. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 2 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
Pembrolizumab, Albumin Paclitaxel, 5-fluorouracil, Cisplatin
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
114 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 31, 2031 | ||||||||
Estimated Primary Completion Date | December 31, 2031 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria: 1.Pathological diagnosis: esophageal squamous cell carcinoma. 2.18-75 years old; 3.Clinical stage II-IVa; 4.no prior antitumor therapy, such as immunotherapy or chemoradiotherapy; 5.ECOG PS score 0-1. 6.Organs function well:Hemoglobin ≥100g/L, white blood cell count ≥4*10^9/L or neutrophil count ≥2.5*10^9/L, platelet count ≥100*10^9/L, serum total bilirubin level ≤1.5 times the upper limit of normal, aspartate aminotransferase (AST) ≤2.5 times the upper limit of normal,Alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal, serum creatinine level below the upper limit of normal or creatinine clearance rate ≥60ml/min, urea nitrogen ≤200mg/L, urinary protein <+, if urinary protein +, 24-hour total protein must be <500mg, blood glucose:In patients with normal-range and/or diabetes under treatment but stable glycemic control, pulmonary function: baseline FEV1 of at least 2L;If the baseline FEV1 was <2L, the predicted FEV1 after surgery was >800ml, and the cardiac function was: no myocardial infarction within 1 year;Unstable angina pectoris;Asymptomatic severe arrhythmias;The centerless function is incomplete; 7.Non-surgically sterilized women, or women of reproductive age, need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during and for 3 months after the end of the study treatment period.Women of childbearing age who were not surgically sterilized had to have a negative serum or urine HCG test within 72 hours before study enrollment.And must be non-lactation period;For male patients with partners of women of childbearing age, effective methods of contraception should be used during the trial period and within 3 months after the last dose of treatment; 8.Sign an informed consent form. Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | China | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT06006650 | ||||||||
Other Study ID Numbers ICMJE | K202208-28 | ||||||||
Has Data Monitoring Committee | Not Provided | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | yanxiaolong, Tang-Du Hospital | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Tang-Du Hospital | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | Tang-Du Hospital | ||||||||
Verification Date | August 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |