OncoMatch

OncoMatch/Clinical Trials/NCT07699185

Neoadjuvant Cardonilizumab Combined With Neoadjuvant Chemoradiotherapy Can Resect Locally Advanced Esophageal Squamous Cell Carcinoma

Is NCT07699185 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Cardonilizumab and Paclitaxel for esophageal squamous cell carcinoma.

Phase 2RecruitingTongji HospitalNCT07699185Data as of Sep 2026Location: China

Treatment: Cardonilizumab · Paclitaxel · CisplatinThis is a multicenter, open-label, randomized, controlled clinical study to compare the efficacy and safety of cardonilizumab combined with neoadjuvant chemotherapy and surgery versus neoadjuvant chemoradiotherapy and surgery in locally advanced ESCC. Subjects were randomly divided into experimental group and control group, the experimental group received neoadjuvant immunotherapy concurrent chemotherapy regimen, the control group received neoadjuvant concurrent chemoradiotherapy regimen, and then received McKeown surgery. The primary outcome measures were complete pathological response (pCR), and the secondary outcome measures were major pathological response (MPR), EFS (event-free survival), OS (overall survival), overall response rate (ORR), decreased pathological stage, R0 resection rate, adverse events (AE), and perioperative complications

Check if I qualify

Extracted eligibility criteria

Treatments studied

Chemotherapy

PaclitaxelCisplatin

Other

Cardonilizumab

Cancer type

Esophageal Carcinoma

Disease stage

Required: Stage CT1N2M0, CT2N0M0, CT2N1M0, CT2N2M0, CT3N0M0, CT3N1M0, CT3N2M0 (other)

pathological stage of cT1N2M0 or cT2-3N0-2M0 according to AJCC Version 8 TNM stage and eligible for R0 surgical resection prior to treatment

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 75

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Cannot have received: anti-PD-1/PD-L1/PD-L2 or co-inhibitory T-cell receptor therapy

Previous treatment with anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that respond to another stimulus or synergistic inhibition of T cell receptors (including but not limited to CTLA-4, OX-40, CD137, etc.)

Cannot have received: systemic anti-tumor therapy

Have not received systematic treatment for the current disease, including surgical treatment, anti-tumor chemoradiotherapy/immunotherapy, etc.

Lab requirements

Blood counts

ANC ≥1.5x10^9/L (no G-CSF in past 14 days); platelets ≥100×10^9/L (no transfusion in past 14 days); hemoglobin >9g/dL (no transfusion or erythropoietin in past 14 days)

Kidney function

Serum creatinine ≤1.5× ULN and creatinine clearance ≥60 ml/min

Liver function

Total bilirubin ≤1.5× ULN; AST and ALT ≤2.5× ULN

Cardiac function

Myocardial enzyme profile within normal range (unless not clinically significant); INR or PT ≤1.5× ULN

For adequate organ function, subjects must meet the following laboratory criteria: ... see full list in inclusion criteria

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07699185 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

What disease stage is eligible?

Stage CT1N2M0 or CT2N0M0 or CT2N1M0 or CT2N2M0 or CT3N0M0 or CT3N1M0 or CT3N2M0 is required.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

Check if I qualify