Anlotinib Hydrochloride Capsules Combined With TQB2450 Injection in Esophageal Squamous Cell Carcinoma Patients (ALTER-E005)

December 14, 2022 updated by: Jiangxi Provincial Cancer Hospital

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Changying Guo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Anlotinib

Patients 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Disease Free Survival
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year DFS rate
Time Frame: 1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year.
One year Disease Free Survival rate
1-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for one year.
3-year DFS rate
Time Frame: 3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years.
Three year Disease Free Survival rate
3-year DFS rate was disease-free survival rate at the time since patients received first dose of treatment regimen for 3 years.
1-year OS rate
Time Frame: 1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year.
One year Overall Survival rate
1-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for one year.
3-year OS rate
Time Frame: 3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years.
Three year Overall Survival rate
3-year OS rate was overall survival rate at the time since patients received first dose of treatment regimen for 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Provincial Cancer Hospital

Collaborators

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Investigators

  • Principal Investigator: Changying Guo, PhD, Jiangxi Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 2, 2022

Primary Completion (ANTICIPATED)

November 1, 2026

Study Completion (ANTICIPATED)

November 1, 2026

Study Registration Dates

First Submitted

January 22, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (ACTUAL)

February 23, 2022

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2022

Last Update Submitted That Met QC Criteria

December 14, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021ky222

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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