Anlotinib in Combination With Sintilimab as Second-line Treatment for Advanced Esophageal Squamous Cell Carcinoma (ESCC) : a Multicenter, Single-arm, Open-label Phase Ⅱ Clinical Trial

Henan Provincial People's Hospital0 sites53 target enrollmentMarch 2021

ConditionsEsophageal Squamous Cell Carcinoma

InterventionsAnlotinib + Sintilimab

DrugsAnlotinib + Sintilimab

Overview

Phase: Not Applicable
Intervention: Anlotinib + Sintilimab
Conditions: Esophageal Squamous Cell Carcinoma
Sponsor: Henan Provincial People's Hospital
Enrollment: 53
Primary Endpoint: Overall survival(OS)
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Detailed Description

China is one of the regions with the highest risk of esophageal cancer in the world, and more than 90% of esophageal cancer is squamous cell carcinoma (SCC). The incidence of esophageal cancer is ranked sixth and the mortality rate ranks fourth in China. At present, the first-line treatment of advanced esophageal cancer is mainly based on the combination of paclitaxel, cisplatin and fluorouracil. After the failure of first-line treatment, there is no standard second-line treatment. The investigators designed a multicenter, single-arm, open-label phase Ⅱ clinical trial of anlotinib combined with sindilimab as second-line treatment for advanced esophageal squamous cell carcinoma (ESCC).

Registry

clinicaltrials.gov

Start Date

March 2021

End Date

January 2022

Last Updated

5 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Henan Provincial People's Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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).
•18\~80 years, both men and women.
•Patients who can provide histological specimens for pathological review.
•Eastern Cooperative Oncology Group(ECOG) performance status 0 or
•Life expectancy of ≥ 12 weeks.
•The main organs function normally, that is, the following criteria are met:
•(1) Blood routine examination:
•ANC ≥ 1.5 × 109 / L;

Exclusion Criteria

•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-L
•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.