Utidelone and Anlotinib in Advanced Recurrent Metastatic Esophageal Cancer

NCT05866510 | Unknown Phase 2

• 1 other identifier: 2022YJZ92
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this clinical trial is to evaluate the safety, tolerance and efficacy of Utidelone combined with Anlotinib in patients with Advanced or Recurrent Esophageal Carcinoma who failed Standard first line therapy.

Conditions

Esophageal Cancer

Keywords

Esophageal Squamous Cell Carcinoma, Utidelone, Anlotinib

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in all participants

  ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: ≥30% decrease in the sum of diameters of target lesions) per RECIST 1.1. For this analysis, ORR will be assessed in all participants who receive at least 1 dose of utidelone and/or anlotinib.

  Up to 1 year

Secondary Outcomes (4)

• progression-free survival (PFS) per RECIST 1.1 in all participants

  Up to 1 year

• duration of response (DOR) per RECIST 1.1 in all participants who achieve partial response (PR) or complete response (CR)

  Up to 1 year

• Overall survival (OS) in all participants

  Up to 2 years

• Incidence of Treatment-Related Adverse Events

  Until 30 days after the last dose of treatment

Study Arms (1)

Utidelone and Anlotinib

EXPERIMENTAL

The treatment group will be treated with Utidelone and Anlotinib until the presence of progressive disease or unacceptable toxicity.

Drug: Utidelone and anlotinib

Interventions

Utidelone and anlotinib DRUG

Pretreatment: diphenhydramine 40 mg by intramuscular injection or oral administration, and dexamethasone10 mg and cimetidine 300 mg by intravenous injection 30 minutes prior to Utidelone iv drip at the first day of each cycle. Utidelone will be given at 30 mg/m2/d administered intravenously on days 1-5 and Anlotinib 8mg/d took orally on days 1-14 every 21 days.

Utidelone and Anlotinib

Eligibility Criteria

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

You may qualify if:

• Histological and/or cytology confirmed advanced or unresectable recurrent esophageal carcinoma
• All patients had failed first-line chemotherapy (disease progression or unacceptable toxicity occurs).
• Patients may also be included if they receive standard neoadjuvant/adjuvant chemotherapy and relapse within 6 months of completion.
• All patients were not accepted any treatment(chemotherapy, radiotherapy, surgery, etc.) within 4 weeks before enrollment.
• The subject has at least one evaluable lesion (measurable or non-measurable) by the RECIST 1.1.
• Male or female, ≥ 18 years of age, ≤ 75 years of age.
• ECOG performance status 0-1.
• Patients with a life expectancy of more than 3 months.
• Baseline routine blood tests within 1 week prior to enrollment is normal. No rhG-CSF use and no blood transfusion/EPO etc. within 14 days prior to enrollment.
• Neutrophil count (ANC) ≥ 1.5 × 109/L.
• Hemoglobin ≥9.0 g/dL.
• platelet count (PLT) ≥ 80 × 109/L
• Blood biochemistry test result is normal within 1 week prior to enrollment (based on normal values at each site's laboratory).
• Total bilirubin (TBIL) ≤ 1.5× the upper limit of normal value (ULN)
• Serum Glutamic Pyruvic Transaminase/Alanine Amino transferase (SGPT /ALT) ≤ 3× ULN (in the case of liver metastases ≤ 5 × ULN)

You may not qualify if:

• Patients who have received antitumor therapy, including chemotherapy, radiotherapy, biologic therapy, targeted therapy, immunotherapy, or antitumor herbal therapy, within 4 weeks. With the exception of the following:
• Nitrosoureas or mitomycin C within 6 weeks prior to the first use of the study drug;
• Oral fluorouracil and small molecule targeted drugs for 2 weeks prior to the first use of the study drug or within the drug's 5 half-life (whichever is longer);
• Chinese medicines with antitumor indications within 2 weeks before the first use of the study drug.
• Major organ surgery (excluding puncture biopsy) within 4 weeks prior to the first dose of study drug had major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks prior to the first dose of study drug, or required elective surgery during the trial.
• Patients with symptomatic peripheral neuropathy with CTCAE 5.0 grade ≥2
• Previous grade 3 or higher neurological related adverse reactions with anti-microtubule drugs.
• Severe allergy to castor oil, or serious adverse effects from previous use of anti-microtubule drugs Those with severe allergy to castor oil or those who have experienced serious adverse reactions to previous anti-microtubule drugs.
• Patients who are pregnant (positive result from the pregnancy test) or lactating.
• Patients whose prior adverse reactions to anti-tumor therapy have not recovered to CTCAE 5.0 grade ≤1 (except for toxicity such as alopecia which poses no safety risk in the judgment of the investigator).
• Patients with symptomatic CNS metastases or meningeal metastases, or uncontrollable metastases.
• Patients with an active infection that currently requires systemic anti-infective therapy, including but not limited to: HIV, active hepatitis B/C infection.
• Patients with history of severe cardiovascular disease
• Patients with mental disorders or poor compliance.
• Subjects who, in the opinion of the investigator, have a history of other serious systemic diseases, or other reasons that make participation in this trial inadvisable.

Sponsors & Collaborators

• Peking University: lead
• Beijing Biostar Pharmaceuticals Co., Ltd.: collaborator
• Chia Tai Tianqing Pharmaceutical Group Co., Ltd.: collaborator

Study Sites (3)

The First Affiliated Hospital of Xinxiang Medical University

Weihui, Henan, 453100, China

NOT YET RECRUITING

Suining Central Hospital

Suining, Sichuan, 629000, China

NOT YET RECRUITING

Beijing Cancer Hospital, Beijing, China

Beijing, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma

Interventions

anlotinib

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lin Shen, MD

CONTACT

008688196561; shenlin@bjmu.edu.cn

Yanshuo Cao, MD

CONTACT

008688196561; yanshuo.cao@bjmu.edu.cn

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: May 7, 2023
• First Posted: May 19, 2023
• Study Start: May 15, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)