Esophageal Cancer
Conditions
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.
Interventions
None listed
Sponsors
Shanghai Chest Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Until 30 day safety follow-up visit | Number of Participants with Adverse Events as a Measure of Safety and Tolerability |
| 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 |
Outcome results
None listed