Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC

NCT07385664 | Not Yet Recruiting Phase 2

• 1 other identifier: IRB-2025-424
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Resectable Esophageal Cancer

Keywords

FAPI-PET/CT; Resectable Esophageal Cancer; Neoadjuvant Therapy

Outcome Measures

Primary Outcomes (2)

• pCR

  Based on the FAPI-PET/CT responders after chemoradiotherapy, the pCR rate of the continued neoadjuvant chemoradiotherapy was over 44%

  up to 12 weeks

• pCR

  Patients with a poor FAPI-PET/CT response after chemoradiotherapy were shifted to concurrent chemoradiotherapy, and the pCR rate was no less than 22%.

  up to 12 weeks

Secondary Outcomes (4)

• MPR

  up to 12 weeks

• DFS

  1 year

• OS

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months

• FAPI-PET/CT response rate

  At the end of Cycle 2(each cycle is 21 days)

Study Arms (1)

Chemotherapy + PD-1 inhibitor

EXPERIMENTAL

Patients initially received 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.

Combination Product: Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy

Interventions

Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy COMBINATION_PRODUCT

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.

Chemotherapy + PD-1 inhibitor

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to understand and voluntarily provide written informed consent before any procedures required for the study are performed.
• Age between 18 and 75 years.
• Eastern Cooperative Oncology Group (ECOG) performance status score 0-1.
• Histologically confirmed esophageal squamous cell carcinoma.
• T1N1-3M0 or T2-4aNanyM0 as determined by endoscopic ultrasound (EUS) or magnetic resonance imaging (MRI) and PET/CT. All lesions, including tumor and lymph nodes, were required to be resectable.
• Tumors with strong FAPI uptake on baseline PET/CT scan should have a maximum standardized uptake value (SUVmax) ≥5.0.
• Subjects were required to provide preoperative paraffin blocks or white slides of tumor tissue, or freshly collected samples, including at least 3 unstained FFPE pathological slides.
• Female subjects of childbearing potential must have a urine or serum pregnancy test with a negative result within 3 days before the first dose. If urine testing could not confirm the negative result, serum testing was required. Participants who had sex with an unsterilized male partner were required to use an effective contraceptive method from the time of screening and to agree to continue using a contraceptive method for 120 days after the last dose. Discontinuation of contraception after 120 days was discussed with the investigator.
• Unsterilized male subjects who have sex with a female partner of childbearing potential are required to use effective contraception from the time of screening until 120 days after the last dose; Discontinuation of contraception after 120 days is also discussed with the investigator.
• Laboratory tests must meet the following criteria:
• Absolute neutrophil count (ANC) ≥ 1500 /µL Platelet count ≥ 100,000/µL Total bilirubin ≤ 2.5 times the upper limit of normal Creatinine clearance (calculated by the following formula) ≥ 60 mL/ minute AST/ALT ≤ 1.5 times the upper limit of normal The modified Cockcroft-Gault equation was used to estimate creatinine clearance (Clcr) : \*\*
• For serum creatinine concentration (Sr Cr) expressed in mg/dL:
• Clcr (mL/min) = (140-age) × actual weight (kg)/(72 × Sr Cr(mg/dL)) Results for women were calculated using 85% of the Clcr values for men.

You may not qualify if:

• Known contraindications include severe allergic reactions to taxanes, platinum-based drugs, 5-FU medications, etc.
• Patients with a documented history of severe allergic reactions to sintilimab.
• Patients who are unwilling or unable to adhere to visit schedules, treatment plans, laboratory tests, and other study requirements.
• Previous radiotherapy administered to the chest or abdomen.
• Patients who have received treatments involving platinum agents, taxanes, 5-FU drugs or PD-1 inhibitors.
• T4 stage tumors exhibiting definite invasion into the spine, heart, major blood vessels or tracheobronchial tree.
• Patients with confirmed cervical or supraclavicular lymph node metastasis or other metastatic lymph nodes that cannot be included in the radiotherapy field nor removed during esophagectomy.
• Patients diagnosed with distant metastases through PET/CT scans or other examinations indicating liver, lung or bone metastases.
• Individuals suffering from significant uncontrolled cardiovascular diseases (such as heart failure), severe coronary artery disease or recent myocardial infarction; also includes those with serious conditions affecting liver or kidney function (e.g., renal insufficiency or liver cirrhosis).
• History of severe central nervous system disorders or mental health issues that may impact treatment compliance and study monitoring.
• Individuals presenting severe surgical contraindications that render them unable to tolerate surgery.

Sponsors & Collaborators

• Ji Yongling: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Interventions

Chemoradiotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Central Study Contacts

Kaiyi Tao, M.D

CONTACT

13867112921; taoky@zjcc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: February 4, 2026
• Study Start: January 28, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 4, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)