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
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
Treatments tested in this trial
- Neoadjuvant Chemoimmunotherapy or Concurrent Chemoradiotherapy
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Ji Yongling
Lead sponsor
Zhejiang Cancer Hospital
Sponsor institution
Source ClinicalTrials.gov