Esophageal carcinoma
Conditions
Interventions
Group A: Two field lymph node dissection:camrelizumab: 200 mg IVGTT D1 once every 3 weeks
21-day cycles
nab-paclitaxel: 260 mg/m2 ivgtt D1 for 1 cycle in 21 days
Cisplatin: 75mg/m2, d1
Administered by intravenous infusion for 1 cycle over 21 days
2 to 4 cycles of continuous administration, and after 4 to 6 weeks of neoadjuvant administration, two field lymph node dissection is performed
Group B: Three field lymph node dissection (cervical lymph nodes include paracervical recurrent laryngeal nerve, paraesophageal and supraclavicular lymph nodes):camrelizumab: 200 mg IVGTT D1 once ever
nab-paclitaxel: 260 mg/m2 IVGTT D1 for 1 cycle in 21 days
2-4 cycles of continuous administration, and after 4 to 6 weeks of neoadjuvant administration, three field lymph node dissection is performed
Sponsors
The First Affiliated Hospital of Zhengzhou University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Subjects should be 18-75 years old; 2) Upper thoracic tumor (20-25cm distance between incisors, subject to cancer center); 3) all subjects must have histologically confirmed esophageal squamous cell carcinoma at the time of initial diagnosis; 4) Clinical stage: T2N0, T1b-2N+ and T3-4aNany (8th edition UICC/AJCC TNM stage); 5) Negative cervical lymph nodes on imaging: defined as lymph nodes with no bilateral supraclavicular region with a short diameter of more than 8mm and a ratio of the long-to-short axis greater than 0.8 as assessed by contrast-enhanced CT and ultrasonography; 6) During the screening period, subjects must undergo PD-L1 expression level testing, which is performed by the central laboratory; Formalin-fixed, paraffin-embedded tissue blocks or unstained tumor tissue sections and relevant pathology reports must be submitted for biomarker evaluation prior to randomization. PD-L1 biomarker analysis must use tumor tissue obtained prior to neoadjuvant therapy (i.e., initial diagnostic biopsy);7) All subjects must be disease-free and undergo a comprehensive physical examination and imaging evaluation within 6 weeks prior to randomization, and the imaging evaluation must include CT/MRI of the neck, chest, and upper abdomen; 8) Performance status must be achieved on a score of 0 or 1 based on ECOG score; 9) Subjects are required to undergo all baseline laboratory evaluations as required, and results should be available within 2 weeks prior to enrollment, and laboratory test values must be screened to meet the following criteria (using CTCAE version 5.0): a. White blood cell count=2000/µL b. Neutrophil count=1500/µL c. Platelet count= 100×103/µL d. Hemoglobin=9.0 g/dL e. Creatinine: serum creatinine =1.5× upper limit of normal (ULN) or creatinine clearance > 50mL/min (according to the Cockcroft-Gault formula) f. Female creatinine clearance = [140-age (years)] × body weight (kg) × 0.85×72× serum creatinine (mg/dL) g. Male creatinine clearance = [140-age (years)] × body weight (kg) × 1.00×72× serum creatinine (mg/dL) h. aspartate aminotransferase (AST) =3×ULN i. Alanine aminotransferase (ALT) =3×ULN j. Total bilirubin =1.5×ULN; 10) Randomization must have been completed within 4 weeks of the end of neoadjuvant therapy Age and reproductive status: 1) Males and females, aged = 18 years 2) Females of childbearing potential must have a negative serum or urine pregnancy test within 48 hours prior to initiation of study drug administration (minimum sensitivity of 25 IU/L or equivalent conversion units for human chorionic gonadotropin), females of childbearing potential are defined as sexually mature females in this study protocol: a. have not undergone hysterectomy or bilateral oophorectomy b. spontaneous menopause has not lasted for 24 consecutive months (amenorrhea after cancer treatment does not preclude childbearing potential), i.e., for 24 consecutive months prior to cancer treatment Menstruation occurs at any time of the month) 3) The woman must not be breastfeeding 4) Females of childbearing potential must agree to comply with the instructions for contraceptive methods for the duration required for 30 days (the entire ovulation cycle) plus roughly 5 half-lives of the study drug, and female subjects receiving the study drug or strict clinical follow-up should use appropriate methods of contraception within 5 months (approximately 5 half-lives of 30 days of the addition of camrelizumab) after receiving the last dose of the study d
Exclusion criteria
Exclusion criteria: 1) Esophageal cancer itself needs to be excluded a. Cervical esophageal cancer or esophageal cancer involving the cervical segment (incisors are more than 20cm away from the upper pole) b. Adenocarcinoma or other pathological types c. Assessed unresectable disease in stage IVB d. Those who have received any form of neoadjuvant therapy prior to surgery (e.g., anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or any other antibodies or in T cells drug therapy with co-stimulation or checkpoint pathways as a specific target) 2) Past medical history and comorbid diseases a. Prior history of other malignancies, unless complete at least 5 years prior to study entry remission, and no other treatment is required or expected to be required for the duration of the study (exceptions, condition including, but not limited to, non-melanoma skin cancer; carcinoma in situ of the bladder or carcinoma in situ of the colon; cervical carcinoma in situ; breast carcinoma in situ, etc.) b. Has a known or suspected active autoimmune disease, inclusion with type I diabetes mellitus, hypothyroidism requiring only hormone replacement therapy, skin diseases that do not require systemic therapy (e.g., vitiligo, psoriasis, or alopecia) or in the absence of external triggers, subjects with diseases that are expected to not recur c. Patients who require systemic treatment with corticosteroids (>10mg daily prednisone or equivalent dose) or other immunosuppressive drugs within 14 days prior to the administration of the study drug; In the absence of active autoimmune diseases, it is allowed to use inhaled or topical steroids and adrenal replacement steroids with a daily equivalent dose of>10mg of prednisone d. Individuals with symptoms or potential to cause drug-related pulmonary toxicity or treatment-related interstitial lung disease e. Individuals who have previously received drug therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibodies or any other antibodies, or with T cell co stimulation or checkpoint pathways as specific targets f. All toxic side effects attributable to previous anti-tumor therapy (preoperative induction therapy) (except for kidney disease, neuropathy, hearing loss, hair loss, and fatigue) must be restored to baseline or level 1 before administering the study drug (CTCAE 5.0 version); For subjects with toxicity attributable to previous anti-cancer treatment, expected to not alleviate, and leading to persistent sequelae (such as peripheral neuropathy after platinum containing treatment), inclusion in the study is allowed; Peripheral neuropathy must be relieved to level 2 (CTCAE version 5.0) g. Any serious or uncontrolled medical illness or active infection that, in the judgment of the researchers, may increase the risk of study participation, study drug administration, or impair the ability of the subjects to receive treatment with the trial protocol h. Known to have a positive history of human immunodeficiency virus (HIV) testing or known to have acquired immunodeficiency syndrome (AIDS) (note: HIV testing must be conducted at a research center mandated by local regulations) i. Any positive test result for hepatitis B virus or hepatitis C virus indicates the presence of the virus, such as positive hepatitis B surface antigen (HBsAg) or positive hepatitis C antibody (anti HCV) (excluding HCV-RNA negative) j. Subjects who received live/attenuated vaccines within 30 days after receiving their first tr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS;Recurrence and metastasis patterns (local recurrence or distant metastasis); | — |
Countries
China
Contacts
Public ContactLi Xiangnan
The First Affiliated Hospital of Zhengzhou University
Outcome results
None listed