Health TrialsbyHealthPanel

Neoadjuvant Chemoimmunotherapy or Chemoradiotherapy in ESCC

ConditionResectable Esophageal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorJi Yongling

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

A history of malignant tumors within the past five years prior to registration (excluding basal cell carcinoma, squamous cell skin cancer, carcinoma in situ of the bladder, or cervical cancer). Patients who have undergone surgical treatment and have remained disease-free for over five years are still eligible for inclusion.

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

66 Participants
are divided into 1 treatment group
Group A: Chemotherapy + PD-1 inhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

pCR

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

Time frame
up to 12 weeks
2

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%.

Time frame
up to 12 weeks

Secondary outcomes

1

MPR

The MPR rate of patients responding to neoadjuvant chemoradiotherapy and FAPI-PET/CT after chemoradiotherapy was based on the MPR rate of patients who continued neoadjuvant chemoradiotherapy, and the MPR rate of patients with a poor FAPI-PET/CT response was converted to concurrent chemoradiotherapy.

Time frame
up to 12 weeks
2

DFS

Disease-free survival. Patients responding to neoadjuvant chemoradiotherapy based on FAPI-PET/CT after chemoradiotherapy had a higher 1-year DFS rate than those not responding.

Time frame
1 year
3

OS

Overall survival

Time frame
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
4

FAPI-PET/CT response rate

The proportion of patients with a change in tumor metabolic activity ≥53% (PET/CT response rate) was evaluated by comparing PFAPI-ET/CT results after chemoradiotherapy as an early predictor of response.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ji Yongling

Lead sponsor

Zhejiang Cancer Hospital

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: