This study will evaluate whether two positron emission tomography/computed tomography (PET/CT) scans performed before treatment-68Ga-FAPI and 18F-FDG-can help predict how well patients with resectable, locally advanced thoracic esophageal squamous cell carcinoma respond to immunotherapy plus chemotherapy given before surgery. The study hypothesis is that information from the two scans can identify patients who are unlikely to have a pathologic complete response (pCR), meaning no remaining cancer in the removed esophagus or lymph nodes, and that retlirafusp alfa may improve pathologic response compared with adebrelimab when each is combined with chemotherapy in these patients.
This study has two stages and plans to enroll 92 adults aged 18 to 75 years with previously untreated, stage II to IVA, resectable thoracic esophageal squamous cell carcinoma. All participants will undergo both PET/CT scans before treatment.
Voluntarily agree to participate in the study and provide written informed consent.
Histologically or cytologically confirmed esophageal squamous cell carcinoma.
Thoracic esophageal cancer assessed by computed tomography (CT), magnetic resonance imaging (MRI), positron emission tomography/computed tomography (PET/CT), or other appropriate imaging, with clinical stage II to IVA disease according to the 8th edition of the American Joint Committee on Cancer (AJCC) staging system.
Considered by a surgeon to be suitable for an R0 resection and planned to undergo surgery after completing neoadjuvant treatment.
Obvious invasion by the tumor or involved lymph nodes into organs adjacent to the esophageal lesion, including the pleura, pericardium, azygos vein, diaphragm, peritoneum, major arteries, vertebral body, or trachea.
Supraclavicular lymph node metastasis.
Diagnosis of another malignant tumor within 5 years before the first administration of study treatment, except for a malignancy with a low risk of metastasis or death and an expected 5-year survival rate greater than 90%. Participants with adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or a similar malignancy may be considered eligible.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
Parallel
Retlirafusp Alfa Plus Chemotherapy
Drugparticipants predicted by the 68Ga-FAPI/18F-FDG dual-imaging model to be unlikely to achieve a pathologic complete response will be randomly assigned to receive retlirafusp alfa in combination with nab-paclitaxel and cisplatin of each 3-week cycle for 2 cycles. Participants without a contraindication to surgery will undergo esophagectomy 4 to 6 weeks after the last treatment dose.
Adebrelimab Plus Chemotherapy
Drugparticipants predicted by the 68Ga-FAPI/18F-FDG dual-imaging model to be unlikely to achieve a pathologic complete response will be randomly assigned to receive Adebrelimab in combination with nab-paclitaxel and cisplatin of each 3-week cycle for 2 cycles. Participants without a contraindication to surgery will undergo esophagectomy 4 to 6 weeks after the last treatment dose.
pCR
Complete Pathological response, no residual viable tumor cells in the primary tumor or lymph nodes.
MPR
Major Pathological Response, the residual tumor cells in the primary tumor were less than 10%.
R0 resection rate
Both ends and circumferential margins were negative
EFS
Event-free survival (EFS) was assessed by the investigator per RECIST 1.1 and was defined as the time from randomization to the occurrence of a study-defined event.
OS
Overall survival (OS) was defined as the time from randomization to death from any cause.
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Tan Lijie
Lead sponsor
Shanghai Zhongshan Hospital
Sponsor institution
Jiangsu Hengrui Pharmaceutical Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
