Anrotenib Plus Toripalimab Versus Toripalimab in Patients With Advanced Esophageal Squamous Cell Carcinoma

NCT04229849 | Unknown Phase 2

• 1 other identifier: HNCH-GI-006
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to investigate the efficacy and safety of anrotenib plus toripalimab in the treatment of advanced esophageal squamous cell carcinoma. In addition, the investigators will explore the possible mechanisms of anrotinib combined with toripalimab in advanced esophageal squamous cell carcinoma, and screen out biomarkers that can predict the efficacy of combination therapy.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From the first day of treatment to death or last survival confirm date

  up to 2 years

Secondary Outcomes (5)

• Progression-free Survival (PFS)

  up to 2 years

• Objective Response Rate (ORR)

  up to 2 years

• Disease Control Rate (DCR)

  up to 2 years

• Number of Participants with Treatment-related Adverse Events Treatment-related adverse events

  up to 2 years

• Assessment of Health-related quality of life

  up to 2 years

Study Arms (2)

Anrotenib plus Toripalimab

EXPERIMENTAL

Anrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days; Until disease progression according to the RECIST 1.1 and irRECIST standard, intolerance of toxicity, withdrawal of informed consent from the subject, or tripleuriumab administration up to 2 years.

Drug: Anrotenib plus Toripalimab

Toripalimab

ACTIVE COMPARATOR

Toripalimab: 240 mg on day 1 intravenously repeated every 21 days; Until disease progression according to the RECIST 1.1 and irRECIST standard, intolerance of toxicity, withdrawal of informed consent from the subject, or tripleuriumab administration up to 2 years.

Drug: Toripalimab

Interventions

Anrotenib plus Toripalimab DRUG

Anrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.

Also known as: FOCUS V

Anrotenib plus Toripalimab

Toripalimab DRUG

Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.

Toripalimab

Eligibility Criteria

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

You may qualify if:

• \. Confirmed esophageal squamous cell carcinoma patients by histopathological or cytopathological examinations.
• \. Advanced esophageal squamous cell carcinoma patients with progression after chemotherapy of taxol and/or platinum or fluorouracil.
• \. According to the evaluation criteria of solid tumor efficacy (RESIST 1.1), there should be at least one measurable lesion (empty organs such as esophagus and stomach cannot be taken as the measurable lesion), and the measurable lesion should not have received local treatment such as radiotherapy (the lesion located in the previous radiotherapy area is also selected as the target lesion if the lesion progression is confirmed).
• \. A histological specimen can be provided for secondary testing.
• \. ≥18 years old, male or female.
• \. ECOG performance status 0-1.
• \. Life expectancy ≥ 12 weeks.
• \. The main organ function meets the following criteria within 7 days before treatment:
• Blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) ≥ 90g/L, the absolute value of neutrophils (ANC) ≥ 1.5 x 10\^9/L, platelet (PLT) ≥ 80 x 10\^9/L.
• Biochemical examinations must meet the following criteria: total bilirubin (TBIL) ≤ 1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 x ULN, serum creatinine (Cr) ≤ 1.5 x ULN or creatinine clearance (CCR) ≥ 60 mL/min.
• Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%).
• \. Fertile men and women must use effective contraception during the study period and within 6 months after the end of the study.
• \. The patient volunteered to participate in the study and signed an informed consent form.

You may not qualify if:

• Patients exceeding or currently suffering from other malignant tumors within 5 years, except for cervical cancer in site, non-melanoma skin cancer and superficial bladder tumors (Ta (non-invasive tumor), Tis (in situ carcinoma), and T1 (tumor infiltrating basement membrane)); Patients with rapid progress within 3 months.
• \. History of gastrointestinal perforation and/or fistula within 6 months prior to the first administration.
• \. Esophageal lesion obviously invading the adjacent organs (major arteries or trachea), resulting in a higher risk of bleeding or fistula.
• \. Received any of the following treatment:
• Previous treatment with anti-PD-1 antibodies or anti-PD-L1 antibodies;
• Received any experimental drug within 4 weeks prior to the first administration of the study drug;
• Enroll in another clinical study, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
• Receive the last dose of anticancer therapy (including radiotherapy, etc.) within 4 weeks before the first administration of the study drug;
• Patients who need to be given corticosteroids (the equivalent dose of \> 10 mg prednisone per day) or other immunosuppressants for systemic treatment within 2 weeks prior to the first use of the study drug, except the use of corticosteroids for esophageal local inflammation and the prevention of allergies, nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical corticosteroid of an equivalent dose of \> 10mg prednisone per day is permitted;
• Received an anti-tumor vaccine or received a live vaccine within 4 weeks prior to the first administration of the study drug
• Received major surgery or severe trauma within 4 weeks prior to first administration of the study drug.
• \. History of immunodeficiency disease, including HIV positive and other acquired or congenital immunodeficiency diseases, or history of organ transplantation allogeneic bone marrow transplantation.
• \. History of allergy to monoclonal antibody or the ingredients of the study drug.
• \. Any severe and/or uncontrolled disease, including:
• Patients with hypertension whose blood pressure can't be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg);

Sponsors & Collaborators

• Henan Cancer Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

toripalimab

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 Officials

• Baoxia He

  Henan Cancer Hospital/The affiliated Cancer Hospital of Zhengzhou University

  STUDY DIRECTOR

Central Study Contacts

Ying Liu

CONTACT

13783604602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2020
• First Posted: January 18, 2020
• Study Start: January 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2022
• Last Updated: January 18, 2020

Record last verified: 2020-01