Head & Neck CancerPhase 2NCT03712397
Nanoliposomal Irinotecan in Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy
A Phase 2 study testing nanoliposomal irinotecan in people with Head & Neck Cancer, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
Trial summary
This is an open-label, single arm, multicenter phase 2 study. The study is to evaluate the activity of a combination therapy with nal-IRI (PEP02, MM-398, Onivyde®) plus 5-FU and leucovorin in patients with squamous cell carcinoma of head \& neck and esophagus failed to platinum-based treatment in prior chemotherapy or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Head & Neck Cancer
- What is being tested?
- nanoliposomal irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 4 sitesTaiwan
- Study dates
- 24 Dec 2018to 31 Dec 2022
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ages ≥ 20 years old
- Histologically confirmed squamous cell carcinoma of esophageal or head \& neck cancers with exclusion of nasopharyngeal carcinoma
- Unresectable locally advanced, recurrent or metastatic diseases ineligible or unsuitable for further surgical or radiation interventions
- Documented disease progression within 6 months after treatment by prior platinum-based systemic chemotherapy or concurrent chemoradiotherapy. Patients who are intolerable to platinum-based systemic chemotherapy after at least 6 weeks' treatment interval or concurrent chemoradiotherapy after at least 3 weeks' treatment interval will be also eligible. Patients who have prior anti-EGFR and anti-PD1/anti-PDL1 treatment will be still eligible.
- ECOG Performance Status 0 and 1
- Documented measurable disease as defined by RECIST v1.1
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- Adequate hematologic parameters, and hepatic and renal functions defined as :absolute neutrophil count ≥ 1,500/μL , platelets ≥ 100,000/μL ,total bilirubin: within normal range ,AST/ALT ≤ 2.5X ULN (≤ 5X ULN if attributable to liver metastases) ,serum creatinine ≤ 2 mg/dL OR creatinine clearance ≥ 40 mL/min (by calculated or 24-hour urine collection)
- Normal ECG or ECG without any clinical significant findings
- Recovered from the effects of any prior surgery, radiotherapy, or other anti- neoplastic therapy
- Able to understand and sign an informed consent (or have a legal representative who is able to do so) (According to inclusion criteria 3 and 4, four distinct patient populations will be enrolled with the following characterizations. (1) patients with metastatic diseases have disease progression while on or within 6 months after last dose of platinum-based chemotherapy; (2) patients with locally advanced diseases have disease progression while on or within 6 months after last dose of platinum-based chemotherapy or chemoradiotherapy; (3) patients with locally advanced diseases have a clinical complete response after platinum-based chemotherapy or chemoradiotherapy. However, the diseases recur within 6 months after completion of treatment and further local treatment were not indicated; (4) patients with metastatic or locally advanced disease but are intolerable to platinum-based chemotherapy after at least 6 weeks' treatment interval or chemoradiotherapy after at least 3 weeks' treatment interval.)
Who cannot join
- Received prior nal-IRI (PEP02, MM-398, Onivyde) or irinotecan therapy
- History of allergic reaction to liposome product, fluropyrimidines, or leucovorin
- Patient with liver cirrhosis with Child-Pugh score ≥ 8 (Late Child-Pugh B and Child-Pugh C)
- Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable
- With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea > grade 1
- With uncontrolled intercurrent illness that could limit study compliance or judged to be ineligible for the study by the investigators including, but not limited to, any of the following: ongoing or active infection requiring antibiotic treatment symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia psychiatric illness or social situation that would preclude study compliance
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- Any major surgery, radiotherapy or anti-cancer therapy within 2 weeks. Patients receiving feeding stomy, esophageal stent and tracheal stent are still eligible to the study
- History of other primary malignancy within 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ, or stage 1 to stage 3 head and neck cancer which is disease-free for two or more years.
- Pregnant or breast feeding women (a urine pregnancy test must be performed on all patients who are of childbearing potential before entering the study, and the result must be negative)
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
Taipei Veterans General Hospital
Taipei
Tri-Service General Hospital
Taipei
About this study
Official title: Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI, PEP02, MM-398, Onivyde®) With 5-FU and Leucovorin in Squamous Cell Carcinoma (SCC) of Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy
This is an open-label, single arm, multicenter phase 2 study. The study is to evaluate the activity of a combination therapy with nal-IRI (PEP02, MM-398, Onivyde®) plus 5-FU and leucovorin in patients with squamous cell carcinoma of head \& neck and esophagus failed to platinum-based treatment in prior chemotherapy or chemoradiotherapy. The primary endpoint is to assess the objective tumor response rate (ORR). Eligible patients will be enrolled to receive combination therapy of nal-IRI plus 5-FU and Leucovorin on day 1, every 2 weeks. Every 2 weeks will be counted as one cycle. Treatment will continue until disease progression, unacceptable toxicity or other condition meeting the discontinuation criteria.
Read the detailed description
This is a phase 2, multicenter, uncontrolled, open-labeled, and one-arm study. Eligible patients will be treated with combination therapy of nal-IRI 80 mg/m2 for 90 minutes, leucovorin 400 mg/m2 for 30 minutes and 5-FU 2400 mg/m2 for 46 hours in sequence at day 1, every 14 days counted as one cycle. Modification of treatment dose is allowed according to the toxicities occurred in the previous treatment cycle. Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.
Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) every 6 weeks.
Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Tumor marker response of SCC antigen will be evaluated by the change of serum SCC antigen level every 6 weeks. Tumor marker response is defined as a decrease of SCC antigen after treatment in relation to the pretreatment level.
Patients sign additional consent to participate in the pharmacogenetic and serum biomarker evaluation will be required to have extra blood samplings at the study entry and every 6 weeks thereafter for up to the maximum 4 times.
A follow-up visit is required approximately 30 days after treatment discontinuation. Overall survival status will be followed by clinic visit or by phone every 3 months until death or the maximum of 3 years, whichever occurs first.
- Conditions
- Head & Neck Cancer
- Being tested
- nanoliposomal irinotecan
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nanoliposomal irinotecanDrug
Also called nal-IRI
combination therapy of nal-IRI , leucovorin and 5-FU in sequence at day 1, every 14 days counted as one cycle
| Study group | Role | What they receive |
|---|---|---|
| nal-IRI in Head & Neck cancer | Experimental | nal-IRI 80 mg/m2 for 90 minutes in sequence at day 1, every 14 days counted as one cycle Receives: Drug: nanoliposomal irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective tumor response rate
Objective tumor response rate
Measured: 6 weeks
Secondary outcomes (4)
Progression-Free Survival (PFS)
Progression-Free Survival (PFS)
Measured: 2-year
Treatment toxicities and safety profiles
Treatment toxicities and safety profiles,assessed by CTCAE v5.0
Measured: 2-year
UGT1A family - UGT1A1 and UGT1A9 with toxicity
to explore the association of the pharmacogenomic data including UGT1A family - UGT1A1 and UGT1A9 with toxicitytoxicity
Measured: 2-year
cytokine and chemokine before and after treatment
to explore the change of serum cytokine and chemokine before and after treatment
Measured: 2-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start24 Dec 2018
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 Head & Neck CancerStudies of the same condition, open and under way.
- 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
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Health Research Institutes, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical University Hospital, Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital
- Responsible party
- Sponsor
- Investigators
- Li-Yuan Bai, PhD, Principal investigator, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712397
- Sponsor's protocol ID
- T2317
- Status last verified
- Apr 2023
- First submitted
- 2 Oct 2018
- Last updated
- 11 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yang MH, Wu SY, Ho IW, Chiang NJ, Hsaio CF, Lin CY, Lien MY, Chang PM, Chen JH, Hsieh CY, Hong RL, Lee CT, Chen LT, Liu TW, Chiu CF, Bai LY. Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial. Cancer Med. 2025 Oct;14(20):e71307. doi: 10.1002/cam4.71307.
PubMed 41117518
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Nanoliposomal Irinotecan (Nal-IRI, PEP02, MM-398, Onivyde®) With 5-FU and Leucovorin in Squamous Cell Carcinoma (SCC) of Head & Neck and Esophagus After Prior Platinum-based Chemotherapy or Chemoradiotherapy
- ClinicalTrials.gov ID
- NCT03712397
- Acronym / sponsor ID
- T2317
- Conditions
- Head & Neck Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- National Health Research Institutes, TaiwanUniversity, hospital or other
- Collaborators
- China Medical University Hospital, Tri-Service General Hospital (TSGH), Taipei Veterans General Hospital, Taiwan, National Cheng-Kung University Hospital
- Study start
- 24 Dec 2018 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 19 Oct 2018 (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 an open-label, single arm, multicenter phase 2 study. The study is to evaluate the activity of a combination therapy with nal-IRI (PEP02, MM-398, Onivyde®) plus 5-FU and leucovorin in patients with squamous cell carcinoma of head \& neck and esophagus failed to platinum-based treatment in prior chemotherapy or chemoradiotherapy. The primary endpoint is to assess the objective tumor response rate (ORR). Eligible patients will be enrolled to receive combination therapy of nal-IRI plus 5-FU and Leucovorin on day 1, every 2 weeks. Every 2 weeks will be counted as one cycle. Treatment will continue until disease progression, unacceptable toxicity or other condition meeting the discontinuation criteria.
Detailed description
This is a phase 2, multicenter, uncontrolled, open-labeled, and one-arm study. Eligible patients will be treated with combination therapy of nal-IRI 80 mg/m2 for 90 minutes, leucovorin 400 mg/m2 for 30 minutes and 5-FU 2400 mg/m2 for 46 hours in sequence at day 1, every 14 days counted as one cycle. Modification of treatment dose is allowed according to the toxicities occurred in the previous treatment cycle. Patients will be treated until disease progression, unacceptable toxicity or other condition meeting the treatment discontinuation criteria.
Tumor response will be assessed according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) every 6 weeks.
Adverse events (AEs) will be evaluated according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0).
Tumor marker response of SCC antigen will be evaluated by the change of serum SCC antigen level every 6 weeks. Tumor marker response is defined as a decrease of SCC antigen after treatment in relation to the pretreatment level.
Patients sign additional consent to participate in the pharmacogenetic and serum biomarker evaluation will be required to have extra blood samplings at the study entry and every 6 weeks thereafter for up to the maximum 4 times.
A follow-up visit is required approximately 30 days after treatment discontinuation. Overall survival status will be followed by clinic visit or by phone every 3 months until death or the maximum of 3 years, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nal-IRI in Head & Neck cancer | Experimental | Drug: nanoliposomal irinotecannal-IRI 80 mg/m2 for 90 minutes in sequence at day 1, every 14 days counted as one cycle |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with ages ≥ 20 years old
- Histologically confirmed squamous cell carcinoma of esophageal or head \& neck cancers with exclusion of nasopharyngeal carcinoma
- Unresectable locally advanced, recurrent or metastatic diseases ineligible or unsuitable for further surgical or radiation interventions
- Documented disease progression within 6 months after treatment by prior platinum-based systemic chemotherapy or concurrent chemoradiotherapy. Patients who are intolerable to platinum-based systemic chemotherapy after at least 6 weeks' treatment interval or concurrent chemoradiotherapy after at least 3 weeks' treatment interval will be also eligible. Patients who have prior anti-EGFR and anti-PD1/anti-PDL1 treatment will be still eligible.
- ECOG Performance Status 0 and 1
Key exclusion criteria (9 listed)
- Received prior nal-IRI (PEP02, MM-398, Onivyde) or irinotecan therapy
- History of allergic reaction to liposome product, fluropyrimidines, or leucovorin
- Patient with liver cirrhosis with Child-Pugh score ≥ 8 (Late Child-Pugh B and Child-Pugh C)
- Active CNS metastasis defined by clinical symptoms, cerebral edema, steroid or anti-convulsant requirement, or progressive growth. Patients with a history of CNS metastasis or cord compression are allowed in the study if they have been treated and are clinically stable
- With clinically significant gastrointestinal disorder including bleeding, inflammation, occlusion or diarrhea > grade 1
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 |
|---|---|---|
| nanoliposomal irinotecanAlso: nal-IRIcombination therapy of nal-IRI , leucovorin and 5-FU in sequence at day 1, every 14 days counted as one cycle | Drug | nal-IRI in Head & Neck cancer |
Primary outcome
Objective tumor response rate
Time frame: 6 weeks
Objective tumor response rate
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: 2-year
Treatment toxicities and safety profiles
Time frame: 2-year
UGT1A family - UGT1A1 and UGT1A9 with toxicity
Time frame: 2-year
cytokine and chemokine before and after treatment
Time frame: 2-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
- Derived from this study: PubMed 41117518Yang MH, Wu SY, Ho IW, Chiang NJ, Hsaio CF, Lin CY, Lien MY, Chang PM, Chen JH, Hsieh CY, Hong RL, Lee CT, Chen LT, Liu TW, Chiu CF, Bai LY. Nanoliposomal Irinotecan in Combination With 5-Fluorouracil and Leucovorin for Advanced Head and Neck and Esophageal Squamous Cell Carcinoma After Prior Platinum-Based Chemotherapy or Chemoradiotherapy: A Multicenter Phase II Trial. Cancer Med. 2025 Oct;14(20):e71307. doi: 10.1002/cam4.71307.
- 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.
Li-Yuan Bai, PhD principal investigator
China Medical University Hospital
4 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 nanoliposomal irinotecan in people with Head & Neck Cancer, run by National Health Research Institutes, Taiwan at 4 sites in Taiwan.
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 10 inclusion and 9 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: finished, as of the sponsor's last update on 11 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 4 sites in Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective tumor response rate (time frame: 6 weeks). 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 NCT03712397, 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 11 Apr 2023.