About this trial
This is a single-arm, exploratory clinical study.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Gender: no restriction; Age: 18-75 years.
Histologically or cytologically confirmed diagnosis of esophageal squamous cell carcinoma.
Clinical stage II-IVa (T2-4aN+M0) according to the AJCC 8th edition, and assessed as resectable by a multidisciplinary team (MDT).
Neck ultrasound and contrast-enhanced chest/abdominal CT.
Disqualifiers
Known history of hypersensitivity to macromolecular protein preparations. Contraindications or allergies to any component of epaplimut-pembrolizumab.
Other anti-tumor therapies (chemotherapy, radiotherapy, surgery, immunotherapy, biological therapy, chemoembolization, anti-tumor traditional Chinese herbal medicine).
Radiographic diagnosis indicating distant metastasis of the tumor.
History of allogeneic tissue/solid organ transplantation.
Trial design
Single group
Treatments tested in this trial
Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel
DrugIparomlimab and Tuvonralimab: 5 mg/kg, Day 1; Lenvatinib: 8 mg, orally, once daily (QD), Day 1-14; Note: Lenvatinib will be discontinued starting from Cycle 3. Cisplatin: 75 mg/m², or Carboplatin: AUC 5, intravenously (IV), Day 1; Nab-paclitaxel: 125 mg/m², Day 1 and Day 8; The cycle repeats every 3 weeks.
Treatment groups
Trial outcomes
Primary outcomes
Pathological Complete Response, pCR
Secondary outcomes
objective response rate (ORR)
Major Pathologic Response(MPR)
In the tumor bed of the surgical resection specimen, necrotic or regressive tumor tissue ≥90 %.
Progression-Free Survival (PFS)
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: