Cadonilimab with paclitaxel micelles and cisplatin before surgery for locally advanced esophageal squamous cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, interventional neoadjuvant trial at the First Affiliated Hospital of Nanjing Medical University testing the combination of cadonilimab (a PD-1/CTLA-4 bispecific antibody) with paclitaxel polymeric micelles and cisplatin. Eligible patients receive 2–4 cycles of the combined therapy before planned surgical resection. Key outcomes include pathologic complete response (pCR) rates, objective response rate (ORR), major pathologic response (MPR), R0 resection rate, 2-year overall and progression-free survival, and safety. The trial enrolls adults with resectable or potentially resectable locally advanced thoracic esophageal squamous cell carcinoma and adequate organ function.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥18 years, ≤75 years, gender is not limited;
2. Squamous esophageal cancer of thoracic segment confirmed by pathology;
3. 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);
4. ECOG PS score of 0-1;
5. No previous antitumor treatment such as radiotherapy, chemotherapy and immunotherapy;
6. Expected survival \> 6 months;
7. 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;
8. Hypertensive patients applying antihypertensive drugs to control blood pressure within the normal range;
9. Diabetic patients with fasting blood glucose controlled at ≤8mmol/L by hypoglycemic drug treatment;
10. No other serious diseases (such as autoimmune diseases, immunodeficiency, organ transplantation, or other diseases that require continuous hormone therapy) that conflict with this protocol;
11. No history of other malignant tumors;
12. The patient agrees to participate in this clinical study and signs the Informed Consent Form.

Exclusion Criteria:

1. Patients who have previously received anti-tumor therapy (including chemotherapy, radiotherapy, surgery or immunotherapy, etc.);
2. Combination of other incurable malignant tumors (except cured non-malignant skin tumors, cervical cancer in situ, and prostate cancer);
3. Patient has or anticipates a significant risk of esophageal perforation, fistula, and hemorrhage;
4. 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;
5. Clinically significant cardiovascular disease including, but not limited to, severe acute myocardial infarction, unstable or severe angina pectoris, coronary artery bypass grafting surgery, congestive heart failure, ventricular arrhythmia requiring medical intervention, left ventricular ejection fraction \<50%, or other anticipated inability to tolerate chemoradiotherapy in the 6 months prior to enrollment;
6. Severe allergies;
7. Pregnant or lactating women;
8. Severe mental disorders;
9. Presence of CTC grade ≥3 peripheral nerve disease;
10. Abnormal coagulation function (PT \> 16s, APTT \> 53s, TT \> 21s, Fib \< 1.5g/L), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;
11. Presence of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, severe impairment of lung function, or active tuberculosis within 1 year;
12. Presence of active hepatitis B or C;
13. Any other condition that the investigator evaluates to be ineligible for enrollment.

Where it's running

• the First Affiliated Hospital of Nanjing Medical University
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Study coordinator: Jing Sun
• Email: sunj@njmu.edu.com
• Phone: 13914704178

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.