NCT07385664

Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC

A Phase II Study of Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy Guided by Post-Chemoimmunotherapy FAPI-PET/CT

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Ji Yongling · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was a single-arm, two-cohort, phase II trial aimed at evaluating the efficacy and safety of FAPI-PET/CT response for guiding the selection of neoadjuvant treatment modes after chemotherapy combined with immunotherapy.

Detailed description

After signing the informed consent form, patients initially underwent two cycles of neoadjuvant chemotherapy in combination with immunotherapy. The chemotherapy protocol consisted of albumin-bound paclitaxel (260mg/m2, with a maximum dose of 400mg) + carboplatin (AUC = 5). Sintilimab was employed for immunotherapy at a fixed dose of 200mg. FAPI-PET/CT was carried out between days 15 and 22 following two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary tumor decreased by more than 53%, the patient was included in the response cohort and continued to receive one or two cycles of neoadjuvant chemotherapy combined with immunotherapy after day 22 after the second chemotherapy, every 3 cycles. The chemotherapy and immunotherapy regimens were the same as those in the first and second cycles. After the completion of three to four cycles of chemotherapy combined with immunotherapy, CT was reviewed, and the resectability was evaluated by surgery. For operable patients, surgical resection would be performed within 4 to 6 weeks. If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by less than 53%, remained unaltered or even increased, the patient was included in the non-response cohort and received concurrent chemoradiotherapy. At the 4th week of concurrent chemoradiotherapy (18 - 23 fractions of radiotherapy), the resectability was assessed through surgery. For operable patients, surgical resection would be carried out within 4 to 6 weeks after the completion of chemoradiotherapy. Patients who failed to achieve pCR after surgery will receive adjuvant sintilimab at a dose of 200mg every 3 weeks for one year. The pCR rate, MPR rate, DFS, OS, FAPI-PET/CT response rate, incidence of postoperative anastomotic leakage, incidence of pneumonia, and quality of life evaluation were observed in patients with or without FAPI response. Meanwhile, the correlation between PD-L1 expression level and PET/CT response was explored, and the feasibility of FAPI-PET/CT response in guiding the selection of neoadjuvant therapy was evaluated.

Conditions

• Resectable Esophageal Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy	FAPI-PET/CT was carried out between days 15 and 22 after two cycles of chemoimmunotherapy. If the FAPI-PET/CT results indicated that the SUVmax of the primary lesion decreased by more than 53%, the patient was included in the response cohort. If the FAPI-PET/CT results showed that the SUVmax of the primary lesion decreased by less than 53%, remained unchanged or even increased, the patient was placed in the non-response cohort and received concurrent chemoradiotherapy.

Timeline

• Start date: 2026-01-28
• Primary completion: 2027-01-30
• Completion: 2028-02-01
• First posted: 2026-02-04
• Last updated: 2026-02-04

Locations

1 site across 1 country: China