Head and Neck Squamous Cell CarcinomasPhase 2NCT04992559
A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
A Phase 2 study testing Consolidation Toripalimab in people with Head and Neck Squamous Cell Carcinomas, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 sites in China.
Trial summary
This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinomas
- What is being tested?
- Consolidation Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesChina
- Study dates
- 22 Jun 2021to 1 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
- Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
- Greater than or equal to 18 and less than 70 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST 1.1.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
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- Adequate hepatic and renal function as demonstrated by
- Serum creatinine < 1.5 X ULN or CrCl > 40mL/min (if using the Cockcroft-Gault formula below):
- Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)）
- Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85
- AST/ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
- Adequate bone marrow function as demonstrated by:
- Absolute Neutrophil Count >1,500/µL
- Platelets > 100 X 103/µL
- Hemoglobin > 9.0 g/dL
- Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days of study enrollment.
- Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 3 months after the last dose of study drugs; "women of reproductive potential" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal; menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes; in addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU/mL.
- Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will be instructed to adhere to contraception for 3 months after the last dose of study drugs; men who are azoospermic do not require contraception.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
Who cannot join
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been cured）.
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Active, known or suspected autoimmune disease.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
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- Has received prior therapy with an anti-PD-1 antibody .
- A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial treatment.
- Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
- Has known active Hepatitis B or C.
- Known history of active TB ( bacillus tuberculosis ).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Song Fan
- Not yet recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Song Fan, Doctor degree, 020-81332471, fansong2@mail.sysu.edu.cn
Song Fan, Doctor degree
About this study
Official title: A Phase II, Open-Label, Single-arm Study of Toripalimab As Consolidation Therapy After Postoperative Radiotherapy or Chemoradiotherapy in Patients With Head and Neck Squamous Cell Carcinomas (HNSCC)
This study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
- Conditions
- Head and Neck Squamous Cell Carcinomas
- Being tested
- Consolidation Toripalimab
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Consolidation ToripalimabDrug
Toripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab Arm | Experimental | Toripalimab consolidation therapy Receives: Drug: Consolidation Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year Disease-Free Survival Rate
The 2-year DFS rate was defined as the rate of progression or death due to disease recurrence within 2 years.
Measured: 2 years
Secondary outcomes (4)
2-year overall survival rate
Number of patients with evidenced death / number of total patients.
Measured: 2 years
Media Disease-free Survival (mDFS)
The time at which disease progression or death due to disease progression occurred in 50% of patients.
Measured: Up to 5 years
Overall survival
Overall survival will be defined as the time from day 1 of study treatment until death from any cause.
Measured: 5 years
Adverse events
Percentage of adverse events that are possibly, probably or definitely related to study treatment.
Measured: 90 days after the first 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 posted5 Aug 2021
- Study start22 Jun 2021
- Primary completion1 Dec 2024 (estimated)
- Study completion1 May 2027 (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 CarcinomasStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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
- 41 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Song Fan, MD, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992559
- Sponsor's protocol ID
- 2021-KY-039
- Status last verified
- Apr 2023
- First submitted
- 28 Jul 2021
- Last updated
- 14 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Open-Label, Single-arm Study of Toripalimab As Consolidation Therapy After Postoperative Radiotherapy or Chemoradiotherapy in Patients With Head and Neck Squamous Cell Carcinomas (HNSCC)
- ClinicalTrials.gov ID
- NCT04992559
- Acronym / sponsor ID
- 2021-KY-039
- Conditions
- Head and Neck Squamous Cell Carcinomas
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 41 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 5 Aug 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 study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Toripalimab Arm | Experimental | Drug: Consolidation ToripalimabToripalimab consolidation therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
- Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
- Greater than or equal to 18 and less than 70 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST 1.1.
Key exclusion criteria (13 listed)
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
- Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been cured）.
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Active, known or suspected autoimmune disease.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
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 |
|---|---|---|
| Consolidation ToripalimabToripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months. | Drug | Toripalimab Arm |
Primary outcome
2-year Disease-Free Survival Rate
Time frame: 2 years
The 2-year DFS rate was defined as the rate of progression or death due to disease recurrence within 2 years.
4 secondary outcomes
2-year overall survival rate
Time frame: 2 years
Media Disease-free Survival (mDFS)
Time frame: Up to 5 years
Overall survival
Time frame: 5 years
Adverse events
Time frame: 90 days after the first dose of study treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2023.
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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.
2 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 Consolidation Toripalimab in people with Head and Neck Squamous Cell Carcinomas, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 2 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 21 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 14 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 2 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Fan, Doctor degrees (13570536658, fansong2@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year Disease-Free Survival Rate (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 14 Apr 2023.