OncoMatch/Clinical Trials/NCT07367516
Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer
Is NCT07367516 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies TQB6411 for esophageal cancer.
Treatment: TQB6411 — The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in subjects with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same patient population.
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anti-PD-1 therapy — recurrent/metastatic
Failure/intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic Esophageal Carcinoma (EC)
Must have received: anti-PD-L1 therapy — recurrent/metastatic
Failure/intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic Esophageal Carcinoma (EC)
Must have received: platinum-based chemotherapy — recurrent/metastatic
Failure/intolerance to prior PD-1/PD-L1 inhibitor plus platinum-based chemotherapy for recurrent/metastatic Esophageal Carcinoma (EC)
Cannot have received: topoisomerase I inhibitor-based antibody-drug conjugate
Prior Treatment with Topoisomerase I Inhibitor-Based ADCs
Cannot have received: irinotecan chemotherapy (irinotecan)
Prior Treatment with...Irinotecan Chemotherapy
Cannot have received: anticancer clinical trial therapy
Prior Participation in Anticancer Clinical Trials Within 4 Weeks
Cannot have received: anticancer therapy
Exception: ≤3 Weeks or Within 5 Half-Lives
Recent Anticancer Treatment (≤3 Weeks or Within 5 Half-Lives)
Cannot have received: anticancer traditional Chinese medicine
Exception: ≤1 Week Prior to Treatment
Recent Use of National Medical Products Administration (NMPA) -Approved Anticancer Traditional Chinese Medicine (≤1 Week Prior to Treatment)
Lab requirements
Blood counts
Hemoglobin (HGB) ≥90 g/L; Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelets (PLT) ≥90×10⁹/L
Kidney function
Serum creatinine (CR) ≤1.3×ULN or creatinine clearance rate (CCR) ≥50 mL/min
Liver function
Total bilirubin (TBIL) ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present)
Laboratory criteria(no hematopoietic growth factor correction within 7 days): Hemoglobin (HGB) ≥90 g/L; Absolute neutrophil count (NEUT) ≥1.5×10⁹/L; Platelets (PLT) ≥90×10⁹/L; Total bilirubin (TBIL) ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present); Serum creatinine (CR) ≤1.3×ULN or creatinine clearance rate (CCR) ≥50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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