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

• Conditions: Esophageal Cancer

• Registration Number: NCT04984096
• Lead Sponsor: Shanghai Chest Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-24
• Study First Submitted QC: 2021-07-24
• Last Update Submitted: 2021-07-24
• Study First Posted: 2021-07-30
• Last Update Posted: 2021-07-30
• Study Start: 2021-08-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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. -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	6 months	PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause

Secondary Outcome Measures

Name	Time	Method
Objective Response Rate (ORR)	each 42 days up to intolerance the toxicity or PD (up to 12 months)	Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
Overall Survival (OS)	12 months	OS is calculated from diagnosis to death or last follow-up time
Adverse Events	Until 30 day safety follow-up visit	Number of Participants with Adverse Events as a Measure of Safety and Tolerability