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

Esophageal Cancer Clinical Trial

— APEC  

Official title:

Treatment Patterns and Clinical Outcomes Among Patients Receiving Anlotinib in Combination With PD-1 Inhibitor for Advanced/Metastatic Esophageal Squamous Cell Carcinoma in Real-world Settings(APEC)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04984096
• Other study ID #: ShanghaiChest RT
• Status: Not yet recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Shanghai Chest Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Chest Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-Free Survival (PFS)	PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause	6 months
Secondary	Adverse Events	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Until 30 day safety follow-up visit
Secondary	Objective Response Rate (ORR)	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).	each 42 days up to intolerance the toxicity or PD (up to 12 months)
Secondary	Overall Survival (OS)	OS is calculated from diagnosis to death or last follow-up time	12 months