NCT05252078 Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients
| NCT ID | NCT05252078 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Jiangxi Provincial Cancer Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-06-02 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2022-06-02 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
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.
Contact & Investigator
Changying Guo, PhD
PRINCIPAL INVESTIGATOR
Jiangxi Provincial Cancer Hospital
Frequently Asked Questions
Who can join the NCT05252078 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05252078 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05252078 currently recruiting?
Yes, NCT05252078 is actively recruiting participants. Contact the research team at guochangying0809@163.com for enrollment information.
Where is the NCT05252078 trial being conducted?
This trial is being conducted at Nanchang, China.
Who is sponsoring the NCT05252078 clinical trial?
NCT05252078 is sponsored by Jiangxi Provincial Cancer Hospital. The principal investigator is Changying Guo, PhD at Jiangxi Provincial Cancer Hospital. The trial plans to enroll 30 participants.