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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Retlirafusp alfa

    Drug

    Administered at a fixed dose of 1800 mg via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles. Retlirafusp alfa must be infused first in the sequence, with an interval of at least 30 minutes before the subsequent administration of nab-paclitaxel.

  • Nab paclitaxel

    Drug

    Administered at a dose of 130 mg/m² via intravenous (IV) infusion on Day 1 and Day 8 of each 21-day cycle (Q3W), for a total of 3 cycles.

  • Cisplatin for injection

    Drug

    Administered at a dose of 75 mg/m² via intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W), for a total of 3 cycles.

Treatment groups

33 Participants
are divided into 1 treatment group
Group A: Retlirafusp Alfa plus Nab-Paclitaxel and CisplatinExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Pathological complete response rate (pCR)

Time frame
Pathological detection after surgery within 1 month

Secondary outcomes

1

Major pathological response rate (MPR)

Time frame
Pathological detection after surgery within 1 month
2

Event-free survival (EFS)

Time frame
from randomization to disease progression that makes surgery impossible, postoperative disease progression, local or distant recurrence, or death from any cause (whichever occurs first，assessed up to 36 months)
3

Overall survival（OS）

Time frame
from randomization to death from any cause，assessed up to 36 months
4

R0 Resection Rate

Time frame
after surgery within 1 month

Other outcomes

Sponsors and contacts

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

Tang-Du Hospital

Lead sponsor

Source ClinicalTrials.gov

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