OncoMatch/Clinical Trials/NCT07367516
Clinical Trial Evaluating TQB6411 Injection in Participant s With Esophageal Cancer
Official title: A Phase Ib/II Clinical Trial Evaluating the Safety and Efficacy of TQB6411 Injection in Participant s With Recurrent or Metastatic Esophageal Cancer Who Have Failed Prior PD-1/PD-L1 Inhibitor Plus Platinum-Based Chemotherapy
Is NCT07367516 recruiting? Yes, currently enrolling (Oct 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 participants 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 participants population.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Esophageal Carcinoma
Disease stage
Required: Stage IV
recurrent or metastatic Esophageal cancer
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anti-PD-1 therapy — recurrent/metastatic Esophageal Carcinoma
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 Esophageal Carcinoma
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 Esophageal Carcinoma
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
Prior Treatment with ...Irinotecan Chemotherapy
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): HGB ≥90 g/L; NEUT ≥1.5×10⁹/L; PLT ≥90×10⁹/L; TBIL ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN if liver metastases present); CR ≤1.3×ULN or CCR ≥50 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT07367516 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior topoisomerase I inhibitor-based antibody-drug conjugate, irinotecan chemotherapy disqualifies patients from enrollment.
What disease stage is eligible?
Stage IV 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 qualifyRelated pages