Combination of Anlotinib and TQB2450 for Esophageal Cancer Treatment

An Open, Single Arm, Multicenter, Exploratory Phase II Clinical Trial of Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients as Postoperative Adjuvant Therapy

This study is testing if combining two medications, Anlotinib and TQB2450, can help people with esophageal cancer stay cancer-free after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangxi Provincial Cancer Hospital (Academic / other)
• Drugs / interventions: prednisone, Anlotinib
• Locations: 1 site (Nanchang, Jiangxi)
• Trial ID: NCT05252078 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with pathologically diagnosed ESCC who have undergone radical resection and require adjuvant therapy.

Not a fit: Patients with concurrent malignancies or those who have received other adjuvant therapies after surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve disease-free survival and overall outcomes for patients with esophageal squamous cell carcinoma.

How similar studies have performed: While this approach is exploratory, similar combination therapies have shown promise in other cancers, suggesting potential for success.

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.

Where this trial is running

Nanchang, Jiangxi

• Jiangxi Cancer Hospital — Nanchang, Jiangxi, China (Recruiting)

Study contacts

• Principal investigator: Changying Guo, PhD — Jiangxi Provincial Cancer Hospital
• Study coordinator: Changying Guo, PhD

Conditions Esophageal Squamous Cell Carcinoma; Esophageal Neoplasms; Esophageal Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Digestive System Neoplasms; Digestive System Diseases; Neoplasms by Site