Head and Neck CancerPhase 2RePASSNCT04126460
High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery(RePASS)
A Phase 2 study testing Toripalimab in people with Head and Neck Cancer, run by Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University at 1 site in China.
Trial summary
This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate the efficacy and safety of adjuvant Toripalimab in high-risk recurrent/secondary HNSCC after salvage surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2019to 31 Dec 2021
- 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. Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the head and neck. Known p16 status for oropharynx carcinoma.
- 2.Patients must have had prior radiation for head and neck SCC with ≥ 75% of the present tumor volume in areas that have been previously irradiated to at least 45 Gy or the intersection between the first irradiation and the reirradiation fields had to be greater than 65%.
- 3. Patients with at least one high risk factors after salvage surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ rStaging III-IV( AJCC 8th).
- 4. No macroscopic residual disease after salvage surgery.
- 5.No distant metastasis.
- 6.Eastern Cooperative Oncology Group Performance Status (ECOG) performance scale: 0-1.
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- 7.Adequate organ and bone marrow function: CBC: absolute neutrophil count (ANC) ≥ 1.5 × 10^9 / L; platelet count (PLT) ≥ 80 × 10^9 / L; hemoglobin content (HGB) ≥ 8.0 g / dL.
- Liver function: serum total bilirubin (TBIL) ≤ 1.5 × normal upper limit (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN.
- Renal function: serum creatinine (Cr) ≤ 1.5 × ULN.
- 8.Female subject of childbearing potential should have a negative urine or serum pregnancy test < 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
- 9.Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile or abstain from heterosexual activity for the course of study therapy through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses > 1 year.
- 10.Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of the study therapy.
- 11.Voluntarily signed written informed consent form, willing and able to comply with scheduled visits and other requirements of the study.
Who cannot join
- 1. Women who are pregnant or lactating.
- 2.Subjects with 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.
- 3.Subjects who are using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment.
- 4.Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to randomization.
- 5.There have been other malignant tumors in the past 5 years, except the cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer.
- 6.Prior therapy with anti-PD-1,anti-PD-L1,anti-CTLA4 antibody.
- 7.Uncontrolled concomitant disease, including but not limited to : Active or poorly controlled severe infection Human Immunodeficiency Virus (HIV) infection (HIV antibody positive) Known acute or chronic active hepatitis B (HBV DNA positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection Active tuberculosis Symptomatic congestive heart failure (New York Heart Association grade III-IV) or symptomatic, poorly controlled arrhythmia Uncontrolled hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke, and transient ischemic attack, within 6 months of enrollment.
- 8.Upon the judgment by the investigator, subjects have other factors that possibly cause the halfway-termination of this study, such as other serious illnesses (including mental illness) requiring concomitant treatment, serious laboratory abnormalities, with family or social factors, which may influence the safety of the subject, or the collection of trial data and samples.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, 200011
Shengjin Dou
About this study
Official title: High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery: The RePASS Study
This is a non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate the efficacy and safety of adjuvant Toripalimab in high-risk recurrent/secondary HNSCC after salvage surgery.
- Conditions
- Head and Neck Cancer
- Being tested
- Toripalimab
- Keywords
- Head and neck, recurrent disease, PD-1, salvage surgery, Second Primary
- Medical subject headings
- Head and Neck Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called JS001
Toripalimab is a type of PD-1 antibody
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab | Experimental | Injection; dosage form: 6ml: 240mg; frequency: 240mgQ3W; duration: 17cycles (12 months) or randomization to the date of the first documented progression Receives: Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year disease-free survival
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 1 year
Measured: 1 year
Secondary outcomes (4)
1 year overall survival
from date of enrollment until date of death from any cause, assessed up to 1 year
Measured: 1 year
1 year local-regional recurrence-free survival
from date of enrollment until date of first documented local-regional recurrence or death from any cause, assessed up to 1 year
Measured: 1 year
1 year distant metastasis-free survival
from date of enrollment until date of first documented distant metastasis or death from any cause, assessed up to 1 year
Measured: 1 year
Treatment-related adverse events (AEs)
The grade of AEs and the number of patients with AEs are assessed by the investigator based on CTCAE v4.0 from the date of enrollment to 90 days after last dose of study treatment
Measured: from the date of enrollment to 90 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2019
- Study start10 Jul 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion31 Dec 2021 (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 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
- 41 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shengjin Dou, Study chair, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126460
- Sponsor's protocol ID
- 2019HNRT02
- Acronym
- RePASS
- Status last verified
- Oct 2019
- First submitted
- 12 Oct 2019
- Last updated
- 15 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- 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 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-risk Recurrent or Second Primary HNSCC With PD-1 Antibody Adjuvant After Salvage Surgery: The RePASS Study
- ClinicalTrials.gov ID
- NCT04126460
- Acronym / sponsor ID
- RePASS / 2019HNRT02
- Conditions
- Head and Neck Cancer
- Keywords
- Head and neck, recurrent disease, PD-1, salvage surgery, Second Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong UniversityUniversity, hospital or other
- Study start
- 10 Jul 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Oct 2019 (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 non-randomized, phase II, open-label study. The goal of this clinical research study is to investigate the efficacy and safety of adjuvant Toripalimab in high-risk recurrent/secondary HNSCC after salvage surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab | Experimental | Drug: ToripalimabInjection; dosage form: 6ml: 240mg; frequency: 240mgQ3W; duration: 17cycles (12 months) or randomization to the date of the first documented progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Pathologically (histologically or cytologically) confirmed diagnosis of recurrent or second primary squamous cell carcinoma (SCC) of the head and neck. Known p16 status for oropharynx carcinoma.
- 2.Patients must have had prior radiation for head and neck SCC with ≥ 75% of the present tumor volume in areas that have been previously irradiated to at least 45 Gy or the intersection between the first irradiation and the reirradiation fields had to be greater than 65%.
- 3. Patients with at least one high risk factors after salvage surgery ①positive margin; ②close margin（<5mm); ③ENE;④PNI;⑤LVI; ⑤ rStaging III-IV( AJCC 8th).
- 4. No macroscopic residual disease after salvage surgery.
- 5.No distant metastasis.
Key exclusion criteria (8 listed)
- 1. Women who are pregnant or lactating.
- 2.Subjects with 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.
- 3.Subjects who are using systemic immunosuppressive agents and continue the dose within 2 weeks prior to the enrollment.
- 4.Is currently participating in and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks prior to randomization.
- 5.There have been other malignant tumors in the past 5 years, except the cured skin basal cell carcinoma, cervical carcinoma in situ and superficial bladder cancer.
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 |
|---|---|---|
| ToripalimabAlso: JS001Toripalimab is a type of PD-1 antibody | Drug | Toripalimab |
Primary outcome
1 year disease-free survival
Time frame: 1 year
from date of enrollment until date of first documented disease progression or death from any cause, assessed up to 1 year
4 secondary outcomes
1 year overall survival
Time frame: 1 year
1 year local-regional recurrence-free survival
Time frame: 1 year
1 year distant metastasis-free survival
Time frame: 1 year
Treatment-related adverse events (AEs)
Time frame: from the date of enrollment to 90 days after last dose of study treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
- 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.
Shengjin Dou study chair
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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 Toripalimab in people with Head and Neck Cancer, 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 13 inclusion and 8 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 Oct 2019. 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?
1 year disease-free survival (time frame: 1 year). 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 Oct 2019.