Health TrialsbyHealthPanel

Paclitaxel Polymeric Micelles and Cisplatin Plus Sintilimab as Neoadjuvant Therapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

ConditionEsophageal Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHebei Medical University Fourth Hospital

About this trial

Locally advanced Esophageal Squamous Cell Carcinoma (ESCC) has poor prognosis with standard therapies. Neoadjuvant immunochemotherapy improves pathological response rates, but optimal regimens remain undefined. Paclitaxel polymeric micelles offer enhanced tumor targeting (EPR effect) and reduced toxicity vs. conventional paclitaxel formulations, with no need for premedication. This single-arm, prospective trial evaluates the efficacy and safety of neoadjuvant sintilimab combined with paclitaxel polymeric micelles and cisplatin in resectable locally advanced ESCC.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Written informed consent was signed before the implementation of any test-related procedures ;

Age 18-75 years ;

Esophageal squamous cell carcinoma confirmed by histopathology ;

Resectable thoracic cT1b-2N1-3M0 or cT2-3N0M0 ;

Disqualifiers

High risk of tracheoesophageal fistula or aortoesophageal fistula

Prior radiotherapy, chemotherapy, targeted therapy, or immunotherapy

Participation in another interventional clinical trial within 4 weeks before the first dose

History of other active malignancies (except cured low-risk tumors, adequately treated non-melanoma skin cancer, or carcinoma in situ)

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel polymer micelles for injection and cisplatin combined with sintilimab

    Drug

    1. Sindilimab : 200 mg, Q3W, intravenous infusion, D1 ; 2. Paclitaxel polymeric micelles : 300 mg/m2 ; q3W, intravenous infusion, D1 ; 3. Cisplatin : 75 mg/m2 ; q3W ; intravenous infusion, D1 ;

Treatment groups

32 Participants
are divided into 1 treatment group
Group A: Paclitaxel polymer micelles and cisplatin combined with sintilimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological Complete Response (pCR) rate

Pathological Complete Response (pCR) rate: Proportion of patients with no residual invasive tumor in primary tumor bed and sampled lymph nodes (ypT0/Tis ypN0) after neoadjuvant therapy

Time frame
Assessed via surgical pathology (4-6 weeks post-neoadjuvant therapy)

Secondary outcomes

1

Major Pathological Response (MPR) rate

Time frame
Perioperative
2

R0 resection rate

Time frame
Perioperative
3

Objective Response Rate (ORR) per RECIST v1.1

Time frame
Assessed at baseline and pre-surgery
4

Event-Free Survival (EFS)

Time frame
Follow-up every 3 months for 2 years, then every 6 months up to 5 years

Other outcomes

Sponsors and contacts

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

Hebei Medical University Fourth Hospital

Lead sponsor

Shanghai Yizhong Pharmaceutical Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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