Oral CancerPhase 1NCT04473716
Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients
A Phase 1 study testing Toripalimab, Paclitaxcel and Cisplatin in people with Oral Cancer and Induction Chemotherapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Cancer, Induction Chemotherapy, Programmed Cell Death 1 Inhibitor
- What is being tested?
- Toripalimab, Paclitaxcel and Cisplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Jul 2020to 30 Sep 2023
- Phase
- Phase 1
- 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
- Eastern cooperative oncology group performance status (ECOG PS) score: 0-1 points
- Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
- Clinical stage of III/IVA (AJCC 2018)
- Blood routine: white blood cells > 3,000/mm3, hemoglobin > 8g/L, platelets > 80,000/mm3
- Liver function: Alanine Transaminase/Aspartate Transaminase <2.5 times the upper limit of normal, bilirubin <1.5 times the upper limit of normal
- Renal function: serum creatinine <1.5 times the upper limit of normal
- Sign the informed consent
Who cannot join
- There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
- Grade 3-4 allergic reactions to Toripalimab, paclitaxcel or cisplatin
- Active severe clinical infection (> CTCAE 5.0 version 2 infection)
- Difficult to control hypertension or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (< 6 months before treatment), myocardial infarction (< 6 months before treatment), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
- Chronic diseases requiring immunotherapy or hormone therapy
- Women during pregnancy or lactation
- Participated in other clinical studies within 30 days before enrollment
- Other circumstances that the investigator thinks are not suitable for participating in the study
Trial locations and contacts
1 site in 1 country.
China1 site
Ninth People's Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
About this study
Official title: Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Read the detailed description
In patients with locally advanced oral squamous cell carcinoma (OSCC), comprehensive treatment is recommended, including surgery, radiotherapy, chemotherapy and others. Pre-operative neoadjuvant therapy can reduce tumor burden, increase organ preservation rate, and reduce distant metastasis rate. Pre-operative neoadjuvant therapy with paclitaxcel and cisplatin (TP) has been used as one of recommended protocols in patients with locally advanced head and neck squamous cell caricnoma, including OSCC. Anti-PD1/PD-L1 immunotherapies have achieved exciting clinical outcomes in several malignancies, such as lung cancer, breast cancer, and so on. Recently, pre-operative neoadjuvant therapy with combination of immunotherapy and chemotherapy agents has been used with good pathological response, which might transfer to good clinical prognosis in patients with malignancies. However, pre-operative neoadjuvant therapy with combination of anti-PD1 and TP in OSCC patients has not been reported. The innovation of this study is the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
- Being tested
- Toripalimab, Paclitaxcel, Cisplatin, Radical surgery, Post-operative radiotherapy/chemoradiotherapy
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called Toripalimab for Injection
Neoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22
PaclitaxcelDrug
Also called Paclitaxel for Injection (Albumin Bound)
Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22
CisplatinDrug
Also called Cisplatin for Injection
Neoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22
Radical surgeryProcedure or surgery
Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.
Post-operative radiotherapy/chemoradiotherapyRadiation
Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin | Experimental | Pre-operative neoadjuvant therapy will be used with the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of paclitaxcel and cisplatin in patients with locally advanced OSCC. After inductive therapy, the patients will receive radical surgery and post-operative radiotherapy/chemoradiotherapy. Receives: Drug: Toripalimab; Drug: Paclitaxcel; Drug: Cisplatin; Procedure: Radical surgery; Radiation: Post-operative radiotherapy/chemoradiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathological response
Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant therapy.
Measured: One year
Secondary outcomes (2)
2-year overall survival
The overall survival time refers to the time from initiating inductive therapy to death due to any cause.
Measured: Two years
2-year tumor recurrence rate
The tumor recurrence rate is calculated using the number of patients with tumor recurrence divided by the total number of patients.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2020
- Study start30 Jul 2020
- Primary completion12 Apr 2021
- Study completion30 Sep 2023
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 Oral CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lai-ping Zhong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
- Investigators
- Lai-ping Zhong, MD, PhD, Principal investigator, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04473716
- Sponsor's protocol ID
- Illuminate trial
- Status last verified
- Nov 2023
- First submitted
- 14 Jul 2020
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Huang Y, Sun J, Li J, Zhu D, Dong M, Dou S, Tang Y, Shi W, Sun Q, Zhao T, Zhou Z, Zhou X, Liu Y, Li J, Zhu G, Zhang D, Chen Y, Zhu Q, Ju W, Zhong L. Neoadjuvant immunochemotherapy for locally advanced resectable oral squamous cell carcinoma: a prospective single-arm trial (Illuminate Trial). Int J Surg. 2023 Aug 1;109(8):2220-2227. doi: 10.1097/JS9.0000000000000489.
PubMed 37288582
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant Toripalimab and Paclitaxel/Cisplatin on Pathological Response in Oral Squamous Cell Carcinoma Patients: A Single-arm Phase I Trial
- ClinicalTrials.gov ID
- NCT04473716
- Acronym / sponsor ID
- Illuminate trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 16 Jul 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.
The aim of this study is to use the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Detailed description
In patients with locally advanced oral squamous cell carcinoma (OSCC), comprehensive treatment is recommended, including surgery, radiotherapy, chemotherapy and others. Pre-operative neoadjuvant therapy can reduce tumor burden, increase organ preservation rate, and reduce distant metastasis rate. Pre-operative neoadjuvant therapy with paclitaxcel and cisplatin (TP) has been used as one of recommended protocols in patients with locally advanced head and neck squamous cell caricnoma, including OSCC. Anti-PD1/PD-L1 immunotherapies have achieved exciting clinical outcomes in several malignancies, such as lung cancer, breast cancer, and so on. Recently, pre-operative neoadjuvant therapy with combination of immunotherapy and chemotherapy agents has been used with good pathological response, which might transfer to good clinical prognosis in patients with malignancies. However, pre-operative neoadjuvant therapy with combination of anti-PD1 and TP in OSCC patients has not been reported. The innovation of this study is the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of TP, as a neoadjuvant therapy to treat the patients with locally advanced OSCC, followed with radical surgery and post-operative radiotherapy/chemoradiotherapy, the major pathological response and safety will be evaluated as the primary surrogate endpoints, the 2-year survival rate and local recurrence rate will be the second endpoints.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin | Experimental | Drug: Toripalimab, Drug: Paclitaxcel, Drug: Cisplatin, Procedure: Radical surgery, Radiation: Post-operative radiotherapy/chemoradiotherapyPre-operative neoadjuvant therapy will be used with the combination of immune checkpoint inhibitor of Toripalimab, and chemotherapy agents of paclitaxcel and cisplatin in patients with locally advanced OSCC. After inductive therapy, the patients will receive radical surgery and post-operative radiotherapy/chemoradiotherapy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Eastern cooperative oncology group performance status (ECOG PS) score: 0-1 points
- Pathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheeks, mouth floor, hard palate, posterior molar region)
- Clinical stage of III/IVA (AJCC 2018)
- Blood routine: white blood cells > 3,000/mm3, hemoglobin > 8g/L, platelets > 80,000/mm3
- Liver function: Alanine Transaminase/Aspartate Transaminase <2.5 times the upper limit of normal, bilirubin <1.5 times the upper limit of normal
Key exclusion criteria (8 listed)
- There are still unresolved toxic reactions above CTCAE level 2 caused by previous anti-cancer treatment
- Grade 3-4 allergic reactions to Toripalimab, paclitaxcel or cisplatin
- Active severe clinical infection (> CTCAE 5.0 version 2 infection)
- Difficult to control hypertension or cardiovascular disease with clinical significance (such as activity)-such as cerebrovascular accident (< 6 months before treatment), myocardial infarction (< 6 months before treatment), unstable angina, New York Cardiology Society (NYHA Appendix 5) congestive heart failure grade II or above, or severe arrhythmia that cannot be controlled with drugs or has potential impact on experimental treatment
- Chronic diseases requiring immunotherapy or hormone therapy
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: Toripalimab for InjectionNeoadjuvant therapy with Toripalimab of 240mg, iv, qd, on day 1, 22 | Drug | Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin |
| PaclitaxcelAlso: Paclitaxel for Injection (Albumin Bound)Neoadjuvant therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22 | Drug | Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin |
| CisplatinAlso: Cisplatin for InjectionNeoadjuvant therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22 | Drug | Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin |
| Radical surgeryRadical surgery will be performed on the 43th-48th after initiation of inductive therapy. | Procedure or surgery | Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin |
| Post-operative radiotherapy/chemoradiotherapyPost-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis. | Radiation | Neoadjuvant therapy with Toripalimab, Paclitaxcel and Cisplatin |
Primary outcome
Major pathological response
Time frame: One year
Major pathological response is based on the pathological examination on the post-operative specimens after neoadjuvant therapy.
2 secondary outcomes
2-year overall survival
Time frame: Two years
2-year tumor recurrence rate
Time frame: Two years
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 22 Nov 2023.
- Derived from this study: PubMed 37288582Huang Y, Sun J, Li J, Zhu D, Dong M, Dou S, Tang Y, Shi W, Sun Q, Zhao T, Zhou Z, Zhou X, Liu Y, Li J, Zhu G, Zhang D, Chen Y, Zhu Q, Ju W, Zhong L. Neoadjuvant immunochemotherapy for locally advanced resectable oral squamous cell carcinoma: a prospective single-arm trial (Illuminate Trial). Int J Surg. 2023 Aug 1;109(8):2220-2227. doi: 10.1097/JS9.0000000000000489.
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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.
Lai-ping Zhong, MD, PhD principal investigator
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 1 study testing Toripalimab, Paclitaxcel and Cisplatin in people with Oral Cancer and Induction Chemotherapy, run by Shanghai Jiao Tong University School of Medicine 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 7 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: finished, as of the sponsor's last update on 22 Nov 2023. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Major pathological response (time frame: One year). 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 NCT04473716, 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 22 Nov 2023.