A Single-arm, Multi-center Exploratory Clinical Study of Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

The First Affiliated Hospital of Zhengzhou University5 sites in 1 country46 target enrollmentMarch 14, 2022

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsAnlotinib+TQB2450

DrugsAnlotinib+TQB2450

Overview

Phase: Phase 2
Intervention: Anlotinib+TQB2450
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: The First Affiliated Hospital of Zhengzhou University
Enrollment: 46
Locations: 5
Primary Endpoint: Objective Response Rate(ORR)
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the effectiveness and safety of anlotinib combined with TQB2450 (PD-L1 inhibitor) in the first-line treatment of patients with advanced ESCC.

Registry

clinicaltrials.gov

Start Date

March 14, 2022

End Date

September 1, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

The First Affiliated Hospital of Zhengzhou University

Responsible Party

Principal Investigator

Feng Wang

Doctor

The First Affiliated Hospital of Zhengzhou University

Eligibility Criteria

Inclusion Criteria

•The patient voluntarily joined the study, signed an informed consent form, had good compliance, and cooperated with the follow-up.
•Unresectable locally advanced, unresectable recurrent or metastatic ESCC confirmed by histopathology (excluding mixed adenosquamous carcinoma);
•Patients who have not received systemic treatment in the past, or who have previously received (neo) adjuvant treatment/radical treatment programs (including radical surgical resection and radical radiotherapy and chemotherapy programs) who have relapsed for more than 6 months; Note: Including patients with advanced or recurring non-target lesions who have progressed again after simple radiotherapy. For local lesions (non-target lesions), the time from the end of palliative treatment to the enrollment time is\> 2 weeks;
•According to the RECIST version 1.1 of the curative effect evaluation standard for solid tumors, there is at least one measurable lesion, and it can be accurately measured by magnetic resonance imaging (MRI) or computed tomography (CT) in at least one direction (the largest diameter needs to be recorded) , Where the longest diameter at baseline is ≥10 mm (if it is a lymph node, the short diameter is required to be ≥15 mm); the measurable lesions should not have received local treatment such as radiotherapy (the lesions located in the previous radiotherapy area, if it is confirmed to have progressed, and meet RECIST1.1 standard, target lesions can also be selected);
•Male or female patients between 18-75 years old;
•Eastern Cooperative Oncology Group (ECOG) physical status (PS) score: 0-1 points;
•The estimated survival period exceeds 3 months;
•Possess sufficient organ and bone marrow function, that is, meet the following standards:
•Routine blood examination standards must be met (no blood transfusion and blood products within 14 days, no correction with G-CSF and other hematopoietic stimulating factors):Hemoglobin content (HB) ≥100g/L; White blood cell content (WBC) ≥3.0×10\^9/L; Neutrophil count (ANC)≥1.5×10\^9/L; Platelet count (PLT) ≥75×10\^9/L.
•The biochemical inspection shall meet the following standards:Total serum bilirubin (TBIL) ≤1.5 times the upper limit of normal (ULN); ALT and AST≤2.5ULN; if there is liver metastasis, ALT and AST≤5ULN;Cr≤1.5ULN or creatinine clearance rate (CCr)≥60ml/min, (Cockcroft-Gault formula).

Exclusion Criteria

•Patients who have previously received Anlotinib hydrochloride treatment or any anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibody treatment;
•It is known that ESCC tends to be completely obstructed under endoscopy and requires interventional therapy to relieve the obstruction;
•ESCC patients with ulcer; Note: This mainly refers to patients whose ulcers are adjacent to blood vessels which increase the risk of bleeding.
•Patients who have received stent implantation in the esophagus or trachea;
•Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula;
•Received major surgical treatment, open biopsy or obvious traumatic injury within 28 days before enrollment;
•There are a variety of factors that affect the use of therapeutic drugs, such as: inability to swallow or chronic diarrhea or intestinal obstruction, significantly affecting the administration and absorption of the drug, or a known history of severe allergies to any of the drug components in this study.
•The patient has received anti-tumor treatment with Chinese medicine in the past 2 weeks (Chinese medicine contains the following medicinal materials such as Brucea javanica, coix seed, lentinan, cantharidin, toad skin, astragalus, sophora flavescens, black bone vine, myrobalan, etc.), However, patients who took more than 2 weeks from the last anti-tumor treatment of Chinese medicine are allowed to join the group;
•The burden of liver metastases accounts for more than 50% of the entire liver volume;
•Patients with any severe and/uncontrolled diseases, including:

Arms & Interventions

Anlotinib combined with TQB2450

Anlotinib: 12mg, capsule, once a day. TQB2450: 1200mg, Injection, Once every three weeks.

Intervention: Anlotinib+TQB2450

Outcomes

Primary Outcomes

Objective Response Rate(ORR)

Time Frame: about 2 years

The RECIST1.1 and iRECIST standards were used to evaluate the efficacy of drugs, with the RECIST1.1 evaluation standard as the main and the iRECIST standard as a supplement.