Esophageal Squamous Cell CarcinomaPhase 2NCT04880811
Afatinib Plus Toripalimab in Previously Treated ESCC With EGFR Overexpression or EGFR Amplification
A Phase 2 study testing Afatinib and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.
Trial summary
This is a phase 2 trial investigating the effect and safety of afatinib plus toripalimab in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- Afatinib and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- Jul 2021to May 2023
- Phase
- Phase 2
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having signed informed consent.
- Age 18 to 70 years old.
- Histologically confirmed esophageal squamous carcinoma
- Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
- Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
- Refractory or intolerant to at least one regimen.
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- Measurable disease according to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 21 days before enrollment)
- Life expectancy of ≥3 month
- Eastern Cooperative Oncology Group (ECOG) 0-2
- WBC>3,000/mm3, absolute neutrophil count ≥1500/mm3, platelet>100,000/mm3, Hb>9g/dl，Bilirubin level < 1.5 times ULN，Serum creatinine <1.5 times ULN，ALT and AST<2.5 times ULN ，AKP < 2.5 times ULN ，(≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
- No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃.
- Good compliance
Who cannot join
- Currently receiving other effective regimens.
- Previous anticipate other clinical trial within 4 weeks before entering this study.
- No measurable lesions, eg. pleural fluid and ascites.
- With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
- Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
- Mentally abnormal or disable cognition,including central nervous system (CNS) metastasis.
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- HIV infection, active hepatitis B or hepatitis C.
- Unstable systemic diseases such as poorly controlled diabetes.
- Interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease showed in X-ray/CT.
- Keratitis, ulcerative keratitis or severe dry eye syndrome. Known hypersensitivity to study drug.
- Pregnancy or lactation period.
- Active severe infection within 14 days
- Contraindications of afatinib.
- Pregnancy (determined by serum β-chorionic gonadotropin test) or breast-feeding
- Gastrointestinal perforation and/or fistula occurred within 3 months before enrollment
- Patients with active autoimmune disease or stable disease with high risk of recurrence
- Use corticosteroids (dose of prednisone or similar drugs> 10mg/day) or other immunosuppressive agents within 14 days before enrollment
- Live vaccine was injected within 4 weeks before enrollment
- Previously received treatment with EFFR-TKI
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Cancer Hospital and Institute
Beijing, Beijing Municipality, 100142
About this study
Official title: Phase 2 Study of Afatinib Plus Toripalimab in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification
This is a phase 2 trial investigating the effect and safety of afatinib plus toripalimab in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- Afatinib, Toripalimab
- Keywords
- afatinib, toripalimab, EGFR Overexpression, EGFR Amplification
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Afatinib is orally administered at 40mg Qd of each 21 day cycle.
ToripalimabDrug
Toripalimab is given by intravenous infusion at 200mg d1 of each 21 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Afatinib plus toripalimab | Experimental | Not described Receives: Drug: Afatinib; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Secondary outcomes (5)
Duration of response
Measure of time from first response to disease progression or death
Measured: Up to 2 years
Disease control rate
Percentage of patients who achieve partial response (PR) or complete response (CR) or stable disease (SD) based on Response Evaluation Criteria In Solid Tumors (RECIST).
Measured: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Incidence of Treatment-Related Adverse Events
Number of adverse events.
Measured: Until 30 days after the last treatment
Progression free survival
Measure of time from study treatment to disease progression or death.
Measured: Up to 2 years
Overall survival
Measure of time from study treatment to patient's death or lost to follow-up.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study startJul 2021 (estimated)
- Primary completionOct 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University Cancer Hospital & Institute
- Investigators
- Lin Shen, Professor, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04880811
- Sponsor's protocol ID
- ESCC-AT
- Status last verified
- Jul 2021
- First submitted
- 6 May 2021
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Afatinib Plus Toripalimab in Previously Treated Recurrent or Metastasic Esophageal Squamous Cell Carcinoma With EGFR Overexpression or EGFR Amplification
- ClinicalTrials.gov ID
- NCT04880811
- Acronym / sponsor ID
- ESCC-AT
- Conditions
- Esophageal Squamous Cell Carcinoma
- Keywords
- afatinib, toripalimab, EGFR Overexpression, EGFR Amplification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Jul 2021 (estimated)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 May 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.
This is a phase 2 trial investigating the effect and safety of afatinib plus toripalimab in previously treated recurrent or metastasic esophageal squamous cell carcinoma with EGFR overexpression or EGFR amplification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Afatinib plus toripalimab | Experimental | Drug: Afatinib, Drug: Toripalimab |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Having signed informed consent.
- Age 18 to 70 years old.
- Histologically confirmed esophageal squamous carcinoma
- Immunohistochemistry confirmed EGFR(3+) or EGFR-FISH-amplification or next generation sequencing confirmed EGFR-amplification.
- Computed tomography (CT) or magnetic resonance imaging (MRI) confirmed unresectable metastasic or recurrent ESCC.
Key exclusion criteria (19 listed)
- Currently receiving other effective regimens.
- Previous anticipate other clinical trial within 4 weeks before entering this study.
- No measurable lesions, eg. pleural fluid and ascites.
- With other malignancy within 5 year, except non-melanoma skin cancer and cervical carcinoma in situ.
- Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AfatinibAfatinib is orally administered at 40mg Qd of each 21 day cycle. | Drug | Afatinib plus toripalimab |
| ToripalimabToripalimab is given by intravenous infusion at 200mg d1 of each 21 day cycle. | Drug | Afatinib plus toripalimab |
Primary outcome
Objective response rate
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST).
5 secondary outcomes
Duration of response
Time frame: Up to 2 years
Disease control rate
Time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Incidence of Treatment-Related Adverse Events
Time frame: Until 30 days after the last treatment
Progression free survival
Time frame: Up to 2 years
Overall survival
Time frame: Up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Lin Shen, Professor principal investigator
Peking University Cancer Hospital & Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Afatinib and Toripalimab in people with Esophageal Squamous Cell Carcinoma, run by Peking University at 1 site in China.
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 12 inclusion and 19 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 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Lin Shen, Professor (86-10-88196561, linshenpku@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2021.