Study of Anlotinib Plus Sintilimab in the Treatment of Advanced Esophageal Squamous Cell Carcinoma

NCT04813406 | Unknown

• 1 other identifier: 2020-115-02
• Study Type: interventional
• Target: 53
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC). In addition, we also explored the possible mechanism of anlotinib combined with sindilimab in order to screen out biomarkers that can predict the efficacy of the combination therapy.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival(OS)

  From date of randomization until the date of death from any cause

  up to 2 year

Secondary Outcomes (3)

• Progress free survival (PFS)

  up to 2 year

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

Study Arms (1)

Anlotinib + Sintilimab

EXPERIMENTAL

Drug: Anlotinib + Sintilimab

Interventions

Anlotinib + Sintilimab DRUG

Anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle. Sintilimab: 200 mg/time, intravenous injection, every 3 weeks is one cycle.

Anlotinib + Sintilimab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathologically (histologically or cytologically) confirmed diagnosis of esophageal squamous cell carcinoma (excluding mixed type adenosquamous carcinoma )
• Patients undergoing first-line systemic chemotherapy (which may include taxanes, platinum and fluorouracil) progression. For radical concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy (chemotherapy or chemoradiotherapy), if disease progression occurs during treatment or within 6 months after stopping treatment, Count it as a first-line treatment failure.（Note: Patients with advanced or relapsed non target lesions who progress again after radiotherapy alone are included. Palliative treatment for local lesions (non target lesions) lasted for more than 2 weeks.）
• At least one measurable/evaluable lesion by RECIST v1.1（Cavity organ such as esophagus can not be used as measurable lesions）. And the measurable lesions should not have received local treatment such as radiotherapy (The lesion located in the previous radiotherapy area, if confirmed to progress, and meets the RECIST 1.1 standard, can also be used as a target lesion).
• \~80 years, both men and women.
• Patients who can provide histological specimens for pathological review.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
• Life expectancy of ≥ 12 weeks.
• The main organs function normally, that is, the following criteria are met:
• (1) Blood routine examination:
• HB≥90g/L;
• ANC ≥ 1.5 × 109 / L;
• PLT ≥ 80 × 109 / L. (2) Biochemical examination:
• TBIL ≤ 1.5ULN
• ALT and AST ≤ 2.5ULN
• plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min

You may not qualify if:

• The patients who had or were suffering from other malignant tumors within 5 years, except for the cured cervical carcinoma in situ, non melanoma skin cancer and superficial bladder tumor \[ta (non-invasive tumor), tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\] and those who developed rapidly within 3 months.
• Patients with a history of perforation and / or fistula within 6 months before the first medication.
• Patients with a high risk of bleeding or perforation due to the apparent invasion of adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed fistulas.
• Have received any of the following treatments:
• Patients who received Sindilimab therapy or other immunotherapy against PD-1/PD-L1.
• Patients who have participated in other drug clinical trials within four weeks.
• Enter another clinical study, unless it is an observational (non intervention) clinical study or an intervention clinical study.
• Receive the last dose of anticancer treatment (including radiotherapy, etc.) within ≤ 4 weeks before the first use of the study drug.
• The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppression purposes (dose \>10 mg/day of prednisone ) and continues to be used within 2 weeks prior to enrollment, except for the use of corticosteroids for local esophageal inflammation and prevention of allergy, nausea and vomiting. In the absence of active autoimmune diseases, inhaled or topical corticosteroids and corticosteroid replacement with a therapeutic dose of prednisone greater than 10 mg / day are permitted.
• Patients who had been vaccinated with anti-tumor vaccine or had been vaccinated with live vaccine within 4 weeks before the first administration of the study drug.
• The patient had major surgery or severe trauma within 4 weeks before the first use of the study drug.
• A history of immunodeficiency, including a positive HIV test or other acquired, congenital immunodeficiency disease, or a history of organ transplantation.
• Allergic to monoclonal antibody and anlotinib
• Patients with any severe and / or uncontrolled disease, include:
• Patients with hypertension who can not be well controlled by antihypertensive drugs (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 100 mmHg).

Sponsors & Collaborators

• Henan Provincial People's Hospital: lead

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

anlotinib; sintilimab

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

Central Study Contacts

Jianwei Zhou, Doctor

CONTACT

0086-13937120756; drzhoujw@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2021
• First Posted: March 24, 2021
• Study Start: March 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: March 24, 2021

Record last verified: 2021-03