OncoMatch/Clinical Trials/NCT05252078
Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
Is NCT05252078 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Anlotinib hydrochloride and TQB2450 for esophageal squamous cell carcinoma.
Treatment: Anlotinib hydrochloride · TQB2450 — This is an Open, Single Arm, Exploratory and Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma (ESCC) Patients as Postoperative Adjuvant Therapy. In order to observe and evaluate the efficacy and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection in treatment of patients with ESCC. The primary endpoint is disease free survival (DFS).
Check if I qualifyExtracted eligibility criteria
Cancer type
Esophageal Carcinoma
Colorectal Cancer
Gastric Cancer
Hepatocellular Carcinoma
Pancreatic Cancer
Cholangiocarcinoma
Disease stage
Required: Stage T1-2N1-3M0, T3-4NANYM0
esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: surgery — radical (R0) resection
Patients received radical (R0) resection of squamous cell carcinoma with no recurrence in imaging examination within 6-12 weeks after surgery, and need adjuvant therapy assessed by the researchers.
Cannot have received: antitumor adjuvant therapy
Exception: after surgical resection
Patients received other antitumor adjuvant therapy after surgical resection.
Cannot have received: targeted therapy (anti-VEGF/VEGFR)
Patients who have received prior targeted therapy (anti-VEGF/VEGFR)
Cannot have received: immunity therapy (anti-PD-1/PD-L1/CTLA-4)
Patients who have received prior immunity therapy (anti-PD-1/PD-L1/CTLA-4)
Lab requirements
Blood counts
Neutrophils count ≥ 1.5 x 10^9/L, platelets count ≥ 75 x 10^9/L, Hb ≥ 90 g/L, WBC ≥ 3 x 10^9/L
Kidney function
Creatinine ≤ 1.5 x ULN
Liver function
total bilirubin ≤ 1.5 x ULN, ALT and AST ≤ 2.5 x ULN
Cardiac function
Myocardial enzymes in the normal range. LVEF ≥ 50%
Laboratory tests must be met: Neutrophils count =/> 1.5 x 10^9/L, platelets count =/> 75 x 10^9/L, Hb =/> 90 g/L, WBC =/> 3 x 10^9/L. total bilirubin =/< 1.5 x ULN, ALT and AST =/< 2.5 x ULN. Creatinine =/< 1.5 x ULN. APTT, INR, PT =/< 1.5 x ULN. TSH =/< ULN. Myocardial enzymes in the normal range. LVEF =/> 50%.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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