A Clinical Study on the Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined With Cadonilimab as a Neoadjuvant Therapy for Locally Advanced Esophageal Squamous Cell Carcinoma: A Single-Arm, Single-Center, Prospective Clinical Trial (POINTS Trial)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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;

• No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy;

• Expected survival \> 6 months;

• Adequate baseline organ function: (i) WBC ≥3×10\^9/L, ANC ≥1.5×10\^9/L, PLT ≥100×10\^9/L, Hb ≥9g/dL; (ii) Liver function: TBIL ≤2ULN, AST ≤2.5ULN, ALT ≤2.5ULN; (iii) Renal function: cCr\>40 ml/min, Cr≤1.5 ULN; (iv) Cardiac function: no cardiac disease or coronary artery disease. Cardiac function: no heart disease or coronary heart disease, patients with cardiac function grade 1-2;

• Hypertensive patients applying antihypertensive drugs to control blood pressure within the normal range;

• Diabetic patients with fasting blood glucose controlled at ≤8mmol/L by hypoglycemic drug treatment;

⁃ No other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy) that conflict with this protocol;

⁃ No history of other malignant tumors;

⁃ The patient agrees to participate in this clinical study and signs the Informed Consent Form.

Locations
Other Locations
China
the First Affiliated Hospital of Nanjing Medical University
RECRUITING
Nanjing
Contact Information
Primary
Jing Sun
sunj@njmu.edu.com
13914704178
Time Frame
Start Date: 2025-04-20
Estimated Completion Date: 2027-10-01
Participants
Target number of participants: 30
Treatments
Experimental: Paclitaxel Polymeric Micelles for Injection and Cisplatin Combined with Cadonilimab
Related Therapeutic Areas
Sponsors
Leads: Sun Jing

This content was sourced from clinicaltrials.gov

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