Anlotinib Combined With TQB2450 (PD-L1 Inhibitor) in the Treatment of Advanced Esophageal Squamous Cell Carcinoma(ESCC)

NCT05038813 | Unknown Phase 2

• 1 other identifier: ALTER-E-003
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

  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.

  about 2 years

Secondary Outcomes (5)

• Safety:adverse events

  about 2 years

• Progression Free Survival(PFS)

  about 2 years

• Disease Control Rate(DCR)

  about 2 years

• Duration of Response(DoR)

  about 2 years

• Overall Survival(OS)

  about 2 years

Study Arms (1)

Anlotinib combined with TQB2450

EXPERIMENTAL

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

Drug: Anlotinib+TQB2450

Interventions

Anlotinib+TQB2450 DRUG

Anlotinib: 12mg, orally once a day (orally before breakfast, the daily medication time should be as the same as possible), continuous taking for 2 weeks, stopping for 1 week, 3 weeks (21 days) as a treatment cycle, until the disease progresses or Intolerable. TQB2450: 1200mg, diluted to 250mL with normal saline, infusion time 60±10mins. The medication is taken on the first day of each cycle, and 3 weeks (21 days) is a treatment cycle. Until the emergence of disease progression or intolerable toxicity, the longest use time does not exceed 24 months.

Anlotinib combined with TQB2450

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Adequate coagulation function, defined as International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN;
• Doppler ultrasound evaluation: left ventricular ejection fraction (LVEF) ≥ lower limit of normal value (50%);
• Myocardial enzyme spectrum: within the normal range.
• Women of childbearing age must take appropriate contraceptive measures from screening to 3 months after stopping the study treatment, and participants must be non-lactating patients. Before starting the administration, the pregnancy test is negative, or meeting one of the following criteria proves that there is no risk of pregnancy:
• Postmenopausal is defined as amenorrhea at least 12 months after the age is over 50 years and all exogenous hormone replacement therapy is stopped;

You may not qualify if:

• 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:
• Patients with poor blood pressure control using antihypertensive drugs (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg); or patients using two or more antihypertensive drugs to control blood pressure; previous hypertensive crisis or high Patients with blood pressure encephalopathy;
• Patients with grade I or higher myocardial ischemia or myocardial infarction, arrhythmia (including QTc interval \>450ms for men and \>470ms for women) and congestive heart failure ≥2 (New York Heart Association (NYHA) classification), severe /Unstable angina) and patients who have undergone coronary/peripheral artery bypass surgery;
• Active or uncontrolled serious infection (≥CTCAE grade 2 infection), and those who are known to have active tuberculosis;
• Renal failure requires hemodialysis or peritoneal dialysis
• Liver diseases such as liver cirrhosis, decompensated liver disease, chronic active hepatitis;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (5)

Anyang Tumour Hospital

Anyang, China

Location

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, China

Location

The First Affiliated Hospital of Nanyang Medical College

Nanyang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

Location

Zhumadian Central Hospital

Zhumadian, China

Location

Related Publications (1)

• Meng X, Yang X, Hong Y, Wang W, Zhang Z, Xia J, Chen Y, Zhou Y, Lu T, Song M, Shan Z, Wu T, Wu W, Shen L, Guan L, Ma M, Wang L, Luo X, Xin D, Ma Y, Jiang G, Qi Y, Jiang B, Zhang D, Hu B, Wu X, Peng Z, Wang F. Anlotinib combined with benmelstobart as a chemo-free first-line treatment in advanced esophageal squamous cell carcinoma: an exploratory multicenter, single-arm phase II clinical trial. Mol Cancer. 2025 Jun 11;24(1):175. doi: 10.1186/s12943-025-02376-w.

  PMID: 40500695 DERIVED

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 6, 2021
• First Posted: September 9, 2021
• Study Start: March 14, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: May 18, 2023

Record last verified: 2023-05

Locations

CN (5)