Esophageal CancerAPECNCT04984096
Anlotinib Combined With PD-1 Inhibitors for Advanced/Metastatic Esophageal Cancer
An observational study of Esophageal Cancer, run by Shanghai Chest Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Cancer
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal squamous cell carcinoma who have received anlotinib combined with PD-1 inhibitors as 2 or more lines treatment.
Who may be able to join
- Male or female patients aged more than 18 years old;
- ECOG PS：0-2;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(ESCC);
- For local advanced or advanced ESCC, disease progression occurred after 1 or more lines systemic treatment previously;
- Have received anlotinib combined with PD-1 inhibitor treatment.
Who cannot join
- have used Anlotinib before;
- mixed with small cell cancer and/or other kinds of cancer ;
- Previously (within 5 years) or presently suffering from other malignancies;
- Symptomatic or uncontrolled brain metastases;
- 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;
- Pregnancy or lactation. -
About this study
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)
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.
Read the 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.
- Conditions
- Esophageal Cancer
- Medical subject headings
- Esophageal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (3)
Adverse Events
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: Until 30 day safety follow-up visit
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).
Measured: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)
OS is calculated from diagnosis to death or last follow-up time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jun Liu, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984096
- Sponsor's protocol ID
- ShanghaiChest RT
- Acronym
- APEC
- Status last verified
- Jul 2021
- First submitted
- 24 Jul 2021
- Last updated
- 30 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhu X, Ma X, Li H, Zhang M, Cheng Y, Wu J, Yu W, Feng W, Zhao L, Li Z, Fu X, Liu J. The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096). Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
PubMed 39711430
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04984096
- Acronym / sponsor ID
- APEC / ShanghaiChest RT
- Conditions
- Esophageal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 30 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal squamous cell carcinoma who have received anlotinib combined with PD-1 inhibitors as 2 or more lines treatment.
Key inclusion criteria (5 listed)
- Male or female patients aged more than 18 years old;
- ECOG PS：0-2;
- Subjects with histologically or cytologically confirmed locally advanced and/or advanced esophageal squamous cell carcinoma(ESCC);
- For local advanced or advanced ESCC, disease progression occurred after 1 or more lines systemic treatment previously;
- Have received anlotinib combined with PD-1 inhibitor treatment.
Key exclusion criteria (6 listed)
- have used Anlotinib before;
- mixed with small cell cancer and/or other kinds of cancer ;
- Previously (within 5 years) or presently suffering from other malignancies;
- Symptomatic or uncontrolled brain metastases;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Progression-Free Survival (PFS)
Time frame: 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
3 secondary outcomes
Adverse Events
Time frame: Until 30 day safety follow-up visit
Objective Response Rate (ORR)
Time frame: each 42 days up to intolerance the toxicity or PD (up to 12 months)
Overall Survival (OS)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2021.
- Derived from this study: PubMed 39711430Zhu X, Ma X, Li H, Zhang M, Cheng Y, Wu J, Yu W, Feng W, Zhao L, Li Z, Fu X, Liu J. The efficacy and safety of anlotinib plus PD-1 inhibitor in locally advanced/metastatic esophageal squamous cell carcinoma (ESCC) patients who progressed on prior immune checkpoint inhibitors (ICIs): a retrospective real-world study (NCT 04984096). Ann Med. 2025 Dec;57(1):2443811. doi: 10.1080/07853890.2024.2443811. Epub 2024 Dec 23.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophageal Cancer, run by Shanghai Chest Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-Free Survival (PFS) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04984096, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.