Neoadjuvant Therapy With Iparomlimab and Tuvonralimab, Lenvatinib and Chemotherapy in Resectable ESCC

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChanghai Hospital

About this trial

This is a single-arm, exploratory clinical study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Design model

Single group

Treatments tested in this trial

  • Iparomlimab and Tuvonralimab+Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxel

    Drug

    Iparomlimab 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

33 Participants
are divided into 1 treatment group
Group A: Iparomlimab and Tuvonralimab + Lenvatinib + Cisplatin/Carboplatin + Nab-paclitaxelExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological Complete Response, pCR

Time frame
Periprocedural

Secondary outcomes

1

objective response rate (ORR)

Time frame
Up to 2 years
2

Major Pathologic Response(MPR)

In the tumor bed of the surgical resection specimen, necrotic or regressive tumor tissue ≥90 %.

Time frame
Periprocedural
3

Progression-Free Survival (PFS)

Time frame
Up to 2 years

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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