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Trial Title:
Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
NCT ID:
NCT06304350
Condition:
Esophageal Cancer
Conditions: Official terms:
Carcinoma, Squamous Cell
Esophageal Neoplasms
Esophageal Squamous Cell Carcinoma
Pembrolizumab
Conditions: Keywords:
esophageal cancer；
Pembrolizumab；
Neoadjuvant therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Combination of pembrolizumab and platinum containing dual drugs
Description:
After 2 courses of treatment with a combination of pembrolizumab and platinum containing
dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab
immunomaintenance therapy continued after surgery
Arm group label:
Combination of pembrolizumab and platinum containing dual drugs
Summary:
This study is a prospective, single center, open label, single arm clinical study. Select
resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer
with pathological diagnosis of squamous cell carcinoma for inclusion, receive
pembrolizumab combined with platinum containing dual drug (albumin
paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery,
continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study
Detailed description:
This study is a prospective, single center, open label, single arm Phase II clinical
study. Patients with locally resectable advanced esophageal squamous cell carcinoma were
selected for inclusion in the study, who received a 2-course neoadjuvant treatment with
pembrolizumab combined with platinum containing dual drugs. After evaluation, surgery was
performed. The efficacy and safety of pembrolizumab combined with chemotherapy
neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma
were observed, with pCR and MPR as the main research endpoints.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM
stage);
2. Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
3. Age range from 18 to 75 years old;
4. There are no surgical contraindications in the preoperative evaluation of various
organ functions;
5. The following laboratory tests confirm that the bone marrow, liver and kidney
functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L;
White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 ×
109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of
normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The
international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit
of normal values, and some prothrombin time is within the normal range; Creatinine ≤
1.5 times the upper limit of normal value;
6. Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy
for malignant tumors, have no history of other malignant tumors, and do not include
prostate cancer patients who have received hormone therapy and have obtained DFS for
more than 5 years;
7. Expected to achieve R0 resection;
8. Physical state ECOG 0-1;
9. The subjects must understand and sign the informed consent form
Exclusion Criteria:
1. Individuals who have received previous treatment for esophageal cancer (surgery,
radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
2. Not suitable for surgery or with surgical contraindications;
3. Have a history of other anti PD-L1/PD-1 treatments;
4. Individuals with immunodeficiency or long-term systemic steroid therapy, or those
who have received any immunosuppressive therapy within 7 days prior to receiving the
study drug;
5. Individuals with active autoimmune diseases requiring systemic treatment within 2
years;
6. Patients with poor control of heart disease
7. Pregnant or lactating female patients;
8. For patients with drug allergies in the protocol.
Exit criteria：
Withdrawal cases refer to subjects who have stopped continuing treatment in clinical
research due to various reasons. Subjects who experience the following situations will
withdraw from the investigational treatment:
1. The main indicators are missing, and more than half of the items that can be filled
in CRF are missing;
2. The surgical procedure violates the plan;
3. Cases that are excluded due to adverse reactions are not evaluated for efficacy, but
side effects should be included in the statistics;
4. According to the researcher's opinion, continuing to participate in the study will
be harmful to their health;
5. Patients who fail to undergo non-surgical treatment due to various reasons,
including malignant tumor progression, underlying disease progression, patient or
their trustee requesting withdrawal, will be reported together;
6. Missing subjects. All subjects who withdrew from the study should record their
reasons for withdrawal in the CRF and their medical records. According to the ITT
principle, all withdrawn cases should undergo survival analysis and toxicity
evaluation for the corresponding group.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Zip:
200080
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiang Fan, MD
Phone:
02163240090
Email:
fan_jiang@tongji.edu.cn
Investigator:
Last name:
Jiang Fan, MD
Email:
Principal Investigator
Start date:
February 17, 2024
Completion date:
December 31, 2026
Lead sponsor:
Agency:
Tongji University
Agency class:
Other
Source:
Tongji University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06304350
