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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients (NCT05252078) is a Phase 2 interventional studying Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, sponsored by Jiangxi Provincial Cancer Hospital. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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).

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Esophageal Squamous Cell Carcinoma and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects volunteered to join the study, signed willing to sign a consent form, good compliance, with follow-up. - ≥ 18 years old. - You should be able to carry out daily activities with 0 level of ability (ECOG 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%. Who Should NOT Join This Trial: - 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 weakened immune system (or active autoimmue disease), or other acquired congenital weakened immune system 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

Anlotinib hydrochloride

Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.

DRUG

TQB2450

TQB2450 is an injection in the form of 600 mg; 1200 mg, iv, D1.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Jiangxi Cancer Hospital
Nanchang, Jiangxi, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05252078), the sponsor (Jiangxi Provincial Cancer Hospital), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05252078 clinical trial studying?

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). The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05252078?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05252078?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05252078. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05252078. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.