NCT05252078

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
6mo left

Started Jun 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jun 2022Nov 2026

First Submitted

Initial submission to the registry

January 22, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 2, 2022

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

4.4 years

First QC Date

January 22, 2022

Last Update Submit

December 14, 2022

Conditions

Esophageal Squamous Cell CarcinomaEsophageal NeoplasmsEsophageal DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesDigestive System NeoplasmsDigestive System DiseasesNeoplasms by SiteNeoplasms by Histologic TypeNeoplasms, Squamous CellCarcinoma, Squamous Cell

Outcome Measures

Primary Outcomes (1)

  • DFS

    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 Outcomes (4)

  • 1-year DFS 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

    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

    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

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

Study Arms (1)

Anlotinib

EXPERIMENTAL

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 hydrochlorideDrug: TQB2450

Interventions

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.

Anlotinib
TQB2450DRUG

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

Anlotinib

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%.

You may not qualify if:

  • 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.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal NeoplasmsEsophageal DiseasesGastrointestinal NeoplasmsGastrointestinal DiseasesDigestive System NeoplasmsDigestive System DiseasesNeoplasms by SiteNeoplasms by Histologic TypeNeoplasms, Squamous CellCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasmsHead and Neck Neoplasms

Study Officials

  • Changying Guo, PhD

    Jiangxi Provincial Cancer Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Changying Guo, PhD

CONTACT

0086-079188313179guochangying0809@163.com

Weimin Mao, PhD

CONTACT

maowm1318@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2022

First Posted

February 23, 2022

Study Start

June 2, 2022

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

CN(1)