Head and Neck Squamous Cell CarcinomaPhase 2IMPORTNCT04523883
Concurrent Immunotherapy With Postoperative Radiotherapy in Intermediate/High Risk HNSCC Patients Unfit for Cisplatin: The IMPORT Study (IMPORT)
A Phase 2 study testing postoperative radiotherapy and JS001 in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- postoperative radiotherapy and JS001
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2020to 9 Aug 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx) 2. With at least one risk factors after radical surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.
- 3. Have at least one contraindication to cisplatin as defined:
- ① Age>65 years old; ②Creatinine clearance (CC) > 30 and < 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female) ((140-Age) / (Serum Creatinine)) (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.
- 4. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following:
- Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
- Platelets count >= 80 * 10^9/l
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- Hemoglobin >= 80 g/dl
- AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
- Total bilirubin <= 1.5 times institutional ULN
- Creatinine clearance >30 ml/min 8. Signed written informed consent
Who cannot join
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment
- Using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Guopei Zhu
Shanghai, 200011
Shengjin Dou, 15800386875, doushengjin@126.com
Guopei Zhu
About this study
Official title: Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- postoperative radiotherapy, JS001
- Keywords
- Head and neck cancer, radiotherapy, PD-1
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
postoperative radiotherapyRadiation
postoperative radiotherapy with a dose of 60-66Gy
JS001Drug
Also called Toripalimab
JS001 240mg every three week
| Study group | Role | What they receive |
|---|---|---|
| concurrent PD-1 | Experimental | Concurrent Immunotherapy With Postoperative Radiotherapy Receives: Radiation: postoperative radiotherapy; Drug: JS001 |
| Radiotherapy alone | Active comparator | Postoperative Radiotherapy alone Receives: Radiation: postoperative radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Measured: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
Secondary outcomes (3)
Overall survival
Measured: from date of enrollment until death from any cause, assessed up to 2 years
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
Acute toxicity profiles, graded according to the NCI CTCAE version 4.0
Measured: up to 3 months after completion of radiotherapy
Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0
Late toxicity profiles, graded according to the NCI CTCAE version 4.0
Measured: from 3 months after completion of radiotherapy 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 posted24 Aug 2020
- Study start10 Aug 2020
- Primary completion9 Aug 2022 (estimated)
- Study completion9 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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
- 316 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University, Eye & ENT Hospital of Fudan University, Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital of Fujian Medical University, Guizhou Provincial People's Hospital, Central South University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04523883
- Sponsor's protocol ID
- 2020HNRT03
- Acronym
- IMPORT
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 15 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Trial of Postoperative Radiotherapy With Concurrent JS001（PD-1 Antibody） vs. Postoperative Radiotherapy Alone in Intermediate/High-risk Head and Neck Cancer Patients With a Contraindication to Cisplatin
- ClinicalTrials.gov ID
- NCT04523883
- Acronym / sponsor ID
- IMPORT / 2020HNRT03
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Keywords
- Head and neck cancer, radiotherapy, PD-1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Collaborators
- Fudan University, Eye & ENT Hospital of Fudan University, Tianjin Medical University Cancer Institute and Hospital, First Affiliated Hospital of Fujian Medical University, Guizhou Provincial People's Hospital, Central South University
- Study start
- 10 Aug 2020 (actual)
- Primary completion
- 9 Aug 2022 (estimated)
- Study completion
- 9 Aug 2024 (estimated)
- First posted
- 24 Aug 2020 (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.
To investigate weather concurrent JS001 with postoperative radiotherapy would have survival benefit in intermediate/high Risk HNSCC Patients who cannot take cisplatin
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| concurrent PD-1 | Experimental | Radiation: postoperative radiotherapy, Drug: JS001Concurrent Immunotherapy With Postoperative Radiotherapy |
| Radiotherapy alone | Active comparator | Radiation: postoperative radiotherapyPostoperative Radiotherapy alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, hypopharynx , or sinuses (excluding nasopharynx) 2. With at least one risk factors after radical surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ pT3-4/N2-3( AJCC 8th).⑥ Level IV/V lymph node metastases for OPC or OC.
- ① Age>65 years old; ②Creatinine clearance (CC) > 30 and < 60 cc/min For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female) ((140-Age) / (Serum Creatinine)) (Weight in kg / 72); ③ Zubrod performance status 2; ④Pre-existing peripheral neuropathy grade ≥ 1; ⑤History of hearing loss, defined as either: ▪ Existing need of a hearing aid OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.
- 4. No distant metastases 5. No synchronous or concurrent head and neck primary tumors 6. ECOG PS 0-2 7. Adequate organ function including the following:
Key exclusion criteria (6 listed)
- Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
- Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
- Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
- Uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia
- Active, known or suspected autoimmune disease such as interstitial pneumonia, uveitis, Crohn's disease, autoimmune thyroiditis. Subjects with cured childhood asthma, type I diabetes mellitus and hypothyroidism only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic 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 |
|---|---|---|
| postoperative radiotherapypostoperative radiotherapy with a dose of 60-66Gy | Radiation | Radiotherapy alone, concurrent PD-1 |
| JS001Also: ToripalimabJS001 240mg every three week | Drug | concurrent PD-1 |
Primary outcome
Disease free survival
Time frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 2 years
3 secondary outcomes
Overall survival
Time frame: from date of enrollment until death from any cause, assessed up to 2 years
Number of participants with treatment-related acute toxicity as assessed weekly by CTCAE v4.0 during the course of treatment
Time frame: up to 3 months after completion of radiotherapy
Number of participants with treatment-related late toxicity as assessed by CTCAE v4.0
Time frame: from 3 months after completion of radiotherapy 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 15 Apr 2021.
- Individual participant dataSharing planned: Undecided
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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.
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 postoperative radiotherapy and JS001 in people with Head and Neck Squamous Cell Carcinoma, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong 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 10 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 15 Apr 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 Shengjin Dou (15800386875, doushengjin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 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 15 Apr 2021.