Clinical trial NCT04984096: Anlotinib Combined With PD-1 Inhibitors for Advanced/Metastatic Esophageal Cancer
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Esophageal Cancer
Lead sponsor: Shanghai Chest Hospital
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophageal squamous cell carcinoma who have received anlotinib combined with PD-1 inhibitors as 2 or more lines treatment.

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.

Eligibility criteria: 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. -

Primary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Until 30 day safety follow-up visit
measure: Objective Response Rate (ORR)
timeFrame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
measure: Overall Survival (OS)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References: