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A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma

ConditionsLocally Advanced Esophageal Squamous Cell CarcinomaNeoadjuvant Therapy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSun Jing

About this trial

The purpose of this study is to investigate the efficacy and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with a PD-1/CTLA-4 bispecific antibody (Cadonilimab) in combination with platinum-containing chemotherapy (Paclitaxel Polymeric Micelles for Injection combined with Cisplatin). Includes pathologic complete remission rates (pCR rates) after 2-4 cycles of Cadonilimab combination chemotherapy. The objective remission rate (ORR), major pathologic remission rate (MPR), R0 resection rate and 2-year overall survival (OS) and progression-free survival (OS) rates, and safety of neoadjuvant treatment of locally advanced esophageal squamous carcinoma with Cadonilimab combined with chemotherapy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years, ≤75 years, gender is not limited;

Squamous esophageal cancer of thoracic segment confirmed by pathology;

Locally advanced patients with no distant metastasis by imaging, resectable or potentially resectable after discussion among oncology, esophageal surgery, and imaging, and clinical stage cT2-4aN+ or cT3-4aN0, M0, stage II, III, or IVA (AJCC 8th edition cTNM staging);

ECOG PS score of 0-1;

Disqualifiers

Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.);

Combination of other incurable malignant tumors (except cured non-malignant skin tumors, cervical cancer in situ, and prostate cancer);

Patient has or anticipates a significant risk of esophageal perforation, fistula, and hemorrhage;

Active autoimmune or immunodeficiency disease, use of immunosuppressants prior to enrollment, and use of immunosuppressant dosage ≥10 mg/day of oral prednisone for more than 2 weeks;

Trial design

Design model

Single group

Treatments tested in this trial

  • Paclitaxel Polymeric Micelles for Injection and Cisplatin combined with Cadonilimab

    Drug

    Paclitaxel Polymeric Micelles for Injection:Cycle 1: 230mg/m2, IV ≥3 hours; Cycles 2-4: If the patient has a neutrophil nadir ≥1.0 x 109/L along with a platelet nadir ≥80 x 109/L after Cycle 1 dosing and has not experienced grade II-IV non-hematologic toxicity, then give 260mg/m2, IV ≥3 hours, d1, q3w; Cisplatin: 25mg/m2/d x d1-3, IV drip, q3w; Cadonilimab: 10mg/kg, IV drip, d3, q3w;

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined with CadonilimabExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Pathological complete response (pCR) rates

evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 2-4 cycles of neoadjuvant therapy.

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Secondary outcomes

1

Objective Rate of Effectiveness (ORR)

the proportion of patients who achieve PR or CR

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
2

R0 Removal Rate

Rate of microscopically margin-negative resection

Time frame
From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.
3

2-year overall survival rate

2-year overall survival rate

Time frame
2 years
4

2-year disease free survival rate

2-year disease free survival rate

Time frame
2 years

Other outcomes

Sponsors and contacts

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

Sun Jing

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Sponsor institution

Source ClinicalTrials.gov
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