Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients

Launched by JIANGXI PROVINCIAL CANCER HOSPITAL · Feb 19, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of two medications, Anlotinib Hydrochloride Capsules and TQB2450 Injection, in patients with esophageal squamous cell carcinoma (ESCC) who have recently undergone surgery. The goal is to see how well this combination works in preventing the cancer from returning after surgery, which is measured by how long patients remain free from disease. The trial is currently seeking participants aged 18 and older who have had successful surgery to remove their cancer and meet specific health criteria.

To be eligible for the trial, patients must have a certain type and stage of esophageal cancer, and they should not have received other cancer treatments after surgery. Participants will need to provide consent and be able to attend follow-up appointments. Throughout the study, they will be monitored for their health and any side effects from the medications. It's important for potential participants to understand the eligibility requirements and discuss with their doctor whether this trial might be a good option for them.

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Eligibility criteria

• 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.