Retlirafusp Alfa Plus Chemotherapy as Neoadjuvant Therapy for Thoracic ESCC
ConditionEsophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorTang-Du Hospital
About this trial
This is a prospective, single-arm, exploratory clinical study designed to evaluate the efficacy and safety of retlirafusp alfa combined with chemotherapy (nab-paclitaxel and cisplatin) as a neoadjuvant therapy for patients with resectable locally advanced thoracic esophageal squamous cell carcinoma (ESCC).
The primary objective of this study is to assess the pathologic complete response (pCR) rate in the target population. A total of 33 patients with histologically or cytologically confirmed resectable locally advanced thoracic ESCC are planned to be enrolled.
Eligibility criteria
Qualifiers
Voluntarily signed and dated written informed consent to participate in this study.
Histologically or cytologically confirmed esophageal squamous cell carcinoma (ESCC).
Clinically staged as thoracic ESCC evaluated by CT, MRI, or endoscopic ultrasonography (EUS), with a clinical stage of T1b-4aN+M0 or T2-4N0M0 according to the American Joint Committee on Cancer (AJCC) 8th edition. For T2N0 patients, at least one high-risk factor must be present: lymphovascular invasion (LVI), tumor size >= 3 cm, or poor differentiation.
Anticipated to achieve an R0 resection.
Disqualifiers
Tumors with clear invasion into adjacent organs of the esophageal lesion (e.g., aorta or trachea).
Presence of supraclavicular lymph node metastasis.
Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage.
Poor nutritional status with Body Mass Index (BMI) < 18.5 kg/m2; however, patients whose nutritional status is corrected after symptomatic nutritional support before enrollment may still be considered after evaluation by the principal investigator.
Trial design
Treatments tested in this trial
- Retlirafusp alfa
- Nab paclitaxel
- Cisplatin for injection
Treatment groups
33 Participants
are divided into 1 treatment groupLocations
1Tangdu Hospital Affiliated to the Fourth Military Medical University710032, Xi'anShaanxi, China
Sponsors and collaborators
Tang-Du Hospital
Lead sponsor
Source ClinicalTrials.gov