Anlotinib Combined With PD-1 Inhibitors for Advanced/Metastatic Esophageal Cancer (APEC)

Shanghai Jiao Tong University

Status: Unknown

Conditions: Esophageal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04984096

ShanghaiChest RT

Details and patient eligibility

About

Efficacy and Safety of Anlotinib combined with PD-1 inhibitors as 2 or more lines treatment for Heavily Pretreated Patients With Advanced, Metastatic Squamous Cell Carcinoma of the Esophagus.

Full description

The APEC study is a multi-center, retrospective ,real-world study of anlotinib combined with PD-1 inhibitors for patients with histologically confirmed advanced and metastatic esophageal squamous cell carcinoma (ESCC) that progressed after 1or more lines of therapy, conducted at 8 sites in China. Patients received anlotinib combined with PD-1 inhibitors , every 3 weeks for up to 2 years, until progression of disease, unacceptable toxic effects occurred, or withdrawal of consent. The primary end point was the progression-free survival (PFS)among all patients. Secondary end points included Adverse events (AEs),objective response rate (ORR) ,duration of response (DOR), , and overall survival (OS). Tumor response was assessed per the Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female patients aged more than 18 years old;
2. ECOG PS：0-2;
3. Subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(ESCC);
4. For local advanced or advanced ESCC, disease progression occurred after 1 or more lines systemic treatment previously;
5. Have received anlotinib combined with PD-1 inhibitor treatment.

Exclusion criteria

1. have used Anlotinib before;
2. mixed with small cell cancer and/or other kinds of cancer ;
3. Previously (within 5 years) or presently suffering from other malignancies;
4. Symptomatic or uncontrolled brain metastases;
5. Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months or serious cardiac arrhythmia requiring medication;
6. Pregnancy or lactation. -