Combination of Anlotinib and TQB2450 for Esophageal Cancer Treatment

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 clinical trial evaluates the effectiveness and safety of Anlotinib Hydrochloride Capsules combined with TQB2450 Injection as postoperative adjuvant therapy for patients with Esophageal Squamous Cell Carcinoma (ESCC). It is an open-label, single-arm Phase II trial focusing on disease-free survival (DFS) as the primary endpoint. Secondary endpoints include overall survival rates and safety assessments based on adverse events. The study aims to provide insights into the potential benefits of this combination therapy for patients who have undergone radical resection of ESCC.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Subjects volunteered to join the study, signed informed consent, good compliance, with follow-up.
* ≥ 18 years old.
* ECOG performance status of 0-1
* Patients with esophageal squamous cell carcinoma pathologically diagnosed as T1-2N1-3M0 or T3-4NanyM0.
* 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.
* Laboratory tests must be met:
* Neutrophils count =/\> 1.5 x 109/L, platelets count =/\> 75 x 109/L, Hb =/\> 90 g/L, WBC =/\> 3 x 109/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%.

Exclusion Criteria:

* Patients received other antitumor adjuvant therapy after surgical resection.
* Concurrent malignancy (except cured basal cell carcinoma of the skin).
* Patients was diagnosed cervical esophageal carcinoma.
* Patients who have received prior targeted therapy (anti-VEGF/VEGFR) or immunity therapy (anti-PD-1/PD-L1/CTLA-4).
* Patients who are allergic to other monoclonal antibodies.
* Patients with a history of immunodeficiency (or active autoimmue disease), or other acquired congenital immunodeficiency diseases.
* Immunosuppressant, systemic, or absorbable local hormone therapy (\> 10mg/ day of prednisone or other equivalent hormone) is required for immunosuppression and continued within 2 weeks of initial administration.
* Patients with multiple factors affecting oral administration.
* Uncontrolled pleural effusion, pericardial effusion or ascites that requires repeated drainage.
* With bleeding tendency. Patients with any bleeding or bleeding event CTC AE grade 3 in the 4 weeks prior to initial administration. The presence of digestive diseases or active bleeding of unresected tumors, or other conditions that the investigator determined which could lead to gastrointestinal bleeding or perforation.
* Active or untreated CNS metastases as determined by CT or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments.
* Patients with hypertension who could not be well controlled by antihypertensive drugs (systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg).
* Patients with myocardial infarction, myocardial ischemia, arrhythmias with poor control (including QTC interval male \> 450 ms, female\> 470 ms) and cardiac insufficiency of grade II according to NYHA standard.
* Active or uncontrolled severe infection (≥ CTC AE Grade 2 infection).
* HIV test positive.
* Proteinuria =/\>2+ and confirmed 24-hour urinary protein quantification \> 1.0 g.
* Vaccination with prophylactic or attenuated vaccine within 4 weeks prior to initial administration.
* According to the investigators' judgment, there are factors that endanger patient or prevent patients from completing the study.

Where it's running

• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Recruiting

Study contacts

• Principal investigator: Changying Guo, PhD — Jiangxi Provincial Cancer Hospital
• Study coordinator: Changying Guo, PhD
• Email: guochangying0809@163.com
• Phone: 0086-079188313179

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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.