An Exploratory Clinical Study of Accurate Efficacy Assessment of Neoadjuvant Immunotherapy in Locally Advanced Esophageal Squamous Cell Carcinoma Based on 68Ga-FAPI ([68Ga] Fibroblast Activation Protein Inhibitor)/¹⁸F-FDG (2-Deoxy-2-[¹⁸F]Fluoro-D-glucose) Dual Imaging

Sponsor
Tan Lijie
Study ID
NCT07770672
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Retlirafusp Alfa Plus Chemotherapy — DRUG
    participants 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 — DRUG
    participants 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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Aug 20, 2026
Status verified
Aug 2026
Primary completion
Mar 1, 2029
Completion
Mar 1, 2029

Study Design

Enrollment
92 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Retlirafusp Alfa Plus Chemotherapy
  • Active Comparator: Adebrelimab Plus Chemotherapy

Primary Outcome Measure

pCR [ Time Frame: One week after surgery ]

Central Contacts

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