Advanced Esophageal Squamous Cell CarcinomaPhase 2NCT05818982
To Evaluate the Efficacy and Safety of Afatinib for Advanced ALTRK-negative ESCC
A Phase 2 study testing Afatinib and Irinotecan in people with Advanced Esophageal Squamous Cell Carcinoma, run by Peking University at 3 sites in China.
Trial summary
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Esophageal Squamous Cell Carcinoma
- What is being tested?
- Afatinib and Irinotecan
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 3 sitesChina
- Study dates
- 9 Feb 2023to Feb 2026
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agree to participate and sign the informed consent form in writing;
- Age: 18-75 years old;
- No gender limit;
- Esophageal squamous cell carcinoma diagnosed by pathology;
- The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative;
- Imagingly confirmed unresectable advanced esophageal squamous cell carcinoma;
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- Failure of previous platinum-containing regimens and immunotherapy regimens (PD-1/PD-L1 monoclonal antibody);
- At least one measurable lesion (according to RECIST1.1 criteria) or non-measurable lesion that can be evaluated, with imaging diagnosis ≤ 21 days from enrollment;
- Estimated survival≥ 3 months;
- General Physical Condition (ECOG) 0-1;
- Sufficient bone marrow hematopoietic function (within 7 days): hemoglobin ≥ 9 g/dL, white blood cell ≥ 3.0×10^9/L, neutrophil ≥1.5×10^9/L, platelet ≥ 100×10^9/L; Normal liver and kidney function (within 14 days): TBIL ≤ 1.5 times the upper limit of normal; ALT and AST ≤ 2.5 times the upper limit of normal, and if liver metastases are present, ≤ 5 times the upper limit of normal; Creatinine ≤ 1.5 times the upper limit of normal;
Who cannot join
- Those who are currently receiving other effective programs;
- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs;
- Those who have received radiotherapy for measurable lesions;
- Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment;
- Patients with other primary malignant tumors other than esophageal cancer at the same time, except for cured skin basal cell carcinoma and cervical carcinoma in situ;
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- Clinically significant cardiovascular diseases, such as heart failure (NYHA GRADE III-IV), uncontrolled coronary heart disease, cardiomyopathy, arrhythmia, uncontrolled hypertension or history of myocardial infarction within the past 1 year;
- Neurological or psychiatric abnormalities affecting cognitive ability, including central nervous system metastases;
- Active severe clinical infection (grade >2 NCI-CTCAE version 5.0) within 14 days prior to enrollment, including active TB;
- Known or reported HIV infection or active hepatitis B or C;
- Uncontrolled systemic diseases, such as poorly controlled diabetes;
- History of interstitial lung disease, such as interstitial pneumonia, pulmonary fibrosis, or evidence of interstitial lung disease on baseline chest x-ray/CT;
- Keratitis, ulcerative keratitis or severe dry eye;
- Known hypersensitivity or anaphylaxis to any component of the investigational drug;
- Pregnancy (determined by serum β-chorionic gonadotropin test) or breastfeeding;
- The investigator determines that there are abnormal heart or lung or kidney or liver function that is not suitable for the treatment of this study;
Trial locations and contacts
3 sites in 1 country.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital, Beijing, China
Beijing
Lin Shen, MD
- Not yet recruiting
First Hospital of Xiamen University Affiliated Hospital,Xiamen,China
Xiamen
Jiayi Li
- Not yet recruiting
Xinxiang Central Hospital of Henan Province, Xinxiang, China
Xinxiang
Yinghua Ji
About this study
Official title: A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
This is a phase II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
Read the detailed description
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.
- Being tested
- Afatinib, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AfatinibDrug
Afatinib will be administered orally at 40 mg per day (qd) in each 6-week cycle.
IrinotecanDrug
Irinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Group A received afatinib (40 mg oral/day) every 6 weeks Receives: Drug: Afatinib |
| Cohort B | Active comparator | Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks Receives: Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.
Measured: 2 years
Secondary outcomes (4)
Objective response rate
The Objective Response Rate (ORR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) based on RECIST version 1.1.
Measured: 2 years
Disease control rate
Disease control rate (DCR) is the percentage of participants who achieved Complete Response (CR) or Partial Response (PR) or Stable disease (SD) based on RECIST version 1.1.
Measured: 2 years
Overall survival
OS is defined as the time from the first dose to the date of death due to any cause.
Measured: 2 years
Adverse Events
Incidence and severity of adverse events.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start9 Feb 2023
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shen Lin, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818982
- Sponsor's protocol ID
- ESCC-ALTRK
- Status last verified
- Apr 2023
- First submitted
- 6 Apr 2023
- Last updated
- 19 Apr 2023
- 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 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Controlled Phase II Study to Evaluate the Efficacy and Safety of Afatinib Versus Irinotecan as a Second-line and Above Treatment for Advanced ALTRK-negative ESCC
- ClinicalTrials.gov ID
- NCT05818982
- Acronym / sponsor ID
- ESCC-ALTRK
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2026 (estimated)
- First posted
- 19 Apr 2023 (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 II study to evaluate the effectiveness and safety of Afininib compared to irinotecan in the 3-gene RNA sequencing (ALTRK) negative advanced esophageal squamous squamous carcinoma.
Detailed description
Participants were assigned to either group A or group B at 2:1 randomization (block randomization). Group A received afatinib (40 mg orally/day) every 6 weeks; Group B received irinotecan (140-180mg/m2 intravenous) every 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: AfatinibGroup A received afatinib (40 mg oral/day) every 6 weeks |
| Cohort B | Active comparator | Drug: IrinotecanGroup B received irinotecan (140-180mg/m2 intravenous) every 2 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Agree to participate and sign the informed consent form in writing;
- Age: 18-75 years old;
- No gender limit;
- Esophageal squamous cell carcinoma diagnosed by pathology;
- The results of 3-gene RNA sequencing (ALTRK) in tumor tissue were negative;
Key exclusion criteria (16 listed)
- Those who are currently receiving other effective programs;
- Patients who have participated in other clinical trials within 4 weeks before enrollment;
- There is no measurable tumor foci, such as fluid accumulation in the body cavity or diffuse infiltration of organs;
- Those who have received radiotherapy for measurable lesions;
- Previous anti-EGFR monoclonal antibody or EGFR-TKI treatment;
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 will be administered orally at 40 mg per day (qd) in each 6-week cycle. | Drug | Cohort A |
| IrinotecanIrinotecan, intravenous drip, 140-180mg/㎡, D1, Q14D | Drug | Cohort B |
Primary outcome
Progression-free survival
Time frame: 2 years
PFS is defined as the time from the first dose to the date of the disease progression or death from any cause.
4 secondary outcomes
Objective response rate
Time frame: 2 years
Disease control rate
Time frame: 2 years
Overall survival
Time frame: 2 years
Adverse Events
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- 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.
3 sites 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 Irinotecan in people with Advanced Esophageal Squamous Cell Carcinoma, run by Peking University at 3 sites 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 11 inclusion and 16 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 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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, MD (+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?
Progression-free survival (time frame: 2 years). 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 19 Apr 2023.