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Esophageal Squamous Cell CarcinomaPhase 2ALTER-E005NCT05252078

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

A Phase 2 study testing Anlotinib hydrochloride and TQB2450 in people with Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Anlotinib hydrochloride and TQB2450
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
2 Jun 2022to Nov 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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 cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Changying Guo, PhD contact

0086-079188313179

guochangying0809@163.com

Weimin Mao, PhD contact

maowm1318@163.com

China1 site, 1 recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

    Changying Guo

    Recruiting

Other trials in China

About this study

Official title: 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 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).

Read the detailed description

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 Esophageal Squamous Cell Carcinoma (ESCC). Primary Efficacy Endpoint: Disease Free Survival (DFS) (According to RECIST Version 1.1), Secondary Efficacy Endpoints:1-year DFS rate, 3-year DFS rate, 1-year Overall Survival (OS) rate, 3-year OS rate, and Safety. Safety and tolerance will be evaluated by incidence, severity and outcomes of AEs and categorized by severity in accordance with the NCI CTC AE Version 5.0.

Being tested
Anlotinib hydrochloride, TQB2450
Medical subject headings
Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms, Esophageal Diseases, Gastrointestinal Neoplasms, Gastrointestinal Diseases, Digestive System Neoplasms, Digestive System Diseases, Neoplasms by Site

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anlotinib hydrochlorideDrug

    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.

  • TQB2450Drug

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

Study groups in NCT05252078
Study groupRoleWhat they receive
AnlotinibExperimentalPatients in the study group will receive the following treatment: 21 days as a treatment cycle, Anlotinib 12 mg/day, Orally (D1-D14); TQB 2450 1200 mg, iv (D1). If anlotinib is not tolerated, the dose can be reduced to 10mg or 8mg, until un-tolerable toxicity again.
Receives: Drug: Anlotinib hydrochloride; Drug: TQB2450

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. DFS

    Disease Free Survival

    Measured: DFS was defined as the time from the day patients received first dose of treatment regimen until the date of first documented recurrence or death from any cause, whichever come first, assessed up to 96 months.

Secondary outcomes (4)

  1. 1-year DFS rate

    One year Disease Free Survival rate

    Measured: 1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year.

  2. 3-year DFS rate

    Three year Disease Free Survival rate

    Measured: 3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years.

  3. 1-year OS rate

    One year Overall Survival rate

    Measured: 1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year.

  4. 3-year OS rate

    Three year Overall Survival rate

    Measured: 3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2022
  2. Study start2 Jun 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05252078
Sponsor's protocol ID
2021ky222
Acronym
ALTER-E005
Status last verified
Dec 2022
First submitted
22 Jan 2022
Last updated
16 Dec 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Anlotinib hydrochloride and TQB2450 in people with Esophageal Squamous Cell Carcinoma and Esophageal Neoplasms, run by Jiangxi Provincial Cancer Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Changying Guo, PhD (0086-079188313179, guochangying0809@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DFS (time frame: DFS was defined as the time from the day patients received first dose of treatment regimen until the date of first documented recurrence or death from any cause, whichever come first, assessed up to 96 months.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05252078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2022.

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