Esophageal cancer
Conditions
Interventions
Trial group:Stratified based on the FAPI PET/CT imaging results, the low-risk response group received surgery after nCIT, and the high-risk/non-response group received surgery after nCIT followed by n
Sponsors
Zhejiang Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Able to understand and voluntarily sign a written informed consent form prior to the performance of any study-specific procedures; 2. Aged between 18 and 75 years; 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0–1; 4. Histologically confirmed esophageal squamous cell carcinoma (ESCC); 5. Clinical stage T1N1–3M0 or T2–4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI), together with PET/CT evaluation. All lesions, including the primary tumor and involved lymph nodes, must be considered resectable; 6. Able to undergo baseline FAPI PET/CT examination. Baseline PET/CT must demonstrate avid FAPI uptake in the primary tumor, with a baseline SUVmax >= 5.0; 7. Availability of pre-treatment tumor tissue specimens, including archived tumor blocks, unstained slides, or newly collected tissue samples, with at least three unstained FFPE slides provided for biomarker analyses; 8. Female participants of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first study treatment. If a urine test result cannot be confirmed as negative, a serum pregnancy test is required. Women of childbearing potential who are sexually active with a non-sterilized male partner must agree to use effective contraception from screening through 120 days after the last dose of study treatment; 9. Male subjects who have not been sterilized and have sexual intercourse with a fertile female partner must take effective contraceptive measures from the time of screening until 120 days after the last administration. Whether to stop contraception after 120 days also needs to be discussed with the researchers.; 10. Adequate organ function demonstrated by the following laboratory criteria: (1) Absolute neutrophil count (ANC) >= 1,500/µL; (2) Platelet count >= 100,000/µL; (3) Total bilirubin = 60 mL/min; (5) AST and ALT <= 1.5 × ULN. Creatinine clearance will be calculated using the modified Cockcroft–Gault formula: CrCl (mL/min) = [(140 - age) × actual body weight (kg)] ÷ [72 × serum creatinine (mg/dL)] × 0.85 (for females).
Exclusion criteria
Exclusion criteria: 1. History of any malignancy within 5 years prior to enrollment, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the bladder, or carcinoma in situ of the cervix; 2. Known severe hypersensitivity or contraindication to taxanes, platinum-based agents, fluoropyrimidines (including 5-FU), or related drugs; 3. History of severe hypersensitivity reaction to serplulimab; 4. Unwillingness or inability to comply with study visits, treatment schedules, laboratory assessments, or other study requirements; 5. Prior radiotherapy to the thoracic or abdominal region; 6. Prior treatment with platinum agents, taxanes, 5-FU, PD-1 inhibitors, or other related anticancer therapies; 7. T4 tumors with definitive invasion of the spine, heart, major vessels, or tracheobronchial tree; 8. Confirmed cervical or supraclavicular lymph node metastases, or other metastatic lymph nodes that cannot be encompassed within the planned radiotherapy field or surgically resected during esophagectomy; 9. Presence of distant metastases confirmed by PET/CT or other diagnostic examinations, including but not limited to liver, lung, or bone metastases; 10. Uncontrolled significant cardiovascular disease (e.g., heart failure, severe coronary artery disease, or recent myocardial infarction) or severe hepatic or renal disease (e.g., liver cirrhosis or renal insufficiency); 11. History of severe central nervous system disorders or psychiatric illness that may interfere with treatment compliance or study monitoring; 12. Major contraindications to surgery or inability to tolerate esophagectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MPR rate in patients with favorable FAPI-PET/CT response and no CT progression (FAPI-responsive group) after continuing nCIT;MPR rate in patients with unfavorable FAPI-PET/CT response or CT progression (FAPI-non-responsive group) after escalating to nCRT; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response (pCR) rate;pT0 rate;ypN0 rate;R0 resection rate;Proportion of residual viable tumor in primary lesion;Lymph node residual tumor burden;Disease-free survival (DFS), overall survival (OS), local-regional recurrence rate, distant metastasis rate;FAPI response rate, dual response rate on CT/FDG, dual non-response rate, and discordance rate;Proportion of patients avoiding neoadjuvant radiotherapy;Completion rate of sequential nCRT in high-risk group;Postoperative anastomotic leak rate, postoperative pneumonia rate, surgical delay rate;Grade =3 treatment-related adverse events (TRAE), immune-related pneumonia, radiation-induced pneumonia, and radiation-induced esophagitis; | — |
Countries
China
Contacts
Public ContactWang Jin
Zhejiang Cancer Hospital
Outcome results
None listed