Oral Squamous Cell CarcinomaPhase 2/3NCT05125055
Neoadjuvant Anti-PD-1 and TP Versus TPF on Pathological Response in OSCC
A Phase 2/3 study testing Toripalimab (anti-programmed death-1 inhibitor), Albumin paclitaxel and Cisplatin in people with Oral Squamous Cell Carcinoma and Neoadjvant Therapy, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Neoadjvant Therapy, Anti-PD-1
- What is being tested?
- Toripalimab (anti-programmed death-1 inhibitor), Albumin paclitaxel and Cisplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Dec 2026
- Phase
- Phase 2/3
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-75 years old
- Gender: male and female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
- Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
- Patients must have at least one measurable lesion according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
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- Blood routine: white blood cells (WBCs) >3,000/mm3, hemoglobin >8 g/L, platelets >80,000/mm3
- Liver function: alanine amino transferase/aspartate amino transferase (ALAT/ASAT) <2.5 times the upper limit of normal and bilirubin <1.5 times the upper limit of normal
- Renal function: Serum creatinine <1.5 times the upper limit of normal
- Coagulation function: INR, PT, APTT<1.5 times the upper limit of normal
- Signed the informed consent form
Who cannot join
- Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments
- Known allergic reaction to any ingredients or excipients of the therapy
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Known history of radiation to head and neck
- Active severe clinical infection (> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
- Obvious cardiovascular abnormalities [such as myocardial infarction, superior vena cava syndrome, grade 2 or higher heart disease diagnosed according to the New York Heart Association (NYHA) classification 3 months before enrollment]
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- Patients receiving immunology-based treatment for any reason
- Patients with a history of active bleeding, coagulopathy, or receiving coumarin anticoagulation therapy
- Pregnant or lactating women
- Uncontrollable hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg) or cardiovascular diseases with clinical significance (such as activity), such as cerebrovascular accidents (≤ 6 months before screening), myocardial infarction (≤6 months before screening), unstable angina pectoris, NYHA grade II or above congestive heart failure, or severe arrhythmia that cannot be controlled by drugs or has a potential impact on trial treatment
- Complicated with severe, uncontrolled infection or known human immunodeficiency virus (HIV) infection, or diagnosed as acquired immunodeficiency syndrome (AIDS); or uncontrolled autoimmune disease; or history of allogeneic tissue/organ transplantation, stem cell or bone marrow transplantation, or solid organ transplantation
- Participation in other clinical trials within 30 days before enrollment
- Other situations that the investigator considers unsuitable with respect to participating in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 20011
Lai-ping Zhong, MD, PhD, +86-21-23271699 ext. 5160, zhonglaiping@163.com
Lai-ping Zhong, MD, PhD
About this study
Official title: Neoadjuvant Toripalimab and Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
Read the detailed description
In the previous "Illuminate" trial, neoadjuvant anti-programmed death-1 (PD-1) of Toripalimab and Albumin paclitaxel /Cisplatin (TTP) therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated. The major pathologic response (MPR) rate was 60% (12/20), including 30% (6/20) pathological complete response (pCR). Furthermore, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized trial, we aimed to compare the pathological response of neoadjuvant TTP therapy versus TPF chemotherapy in the patients with locally advanced OSCC (Illuminate-2 trial). A total of 80 patients will be enrolled in this trial, and the primary endpoint is MPR rate. The neoadjuvant TTP arm will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD1 inhibitor, 240 mg) on d1 and d22, followed by the standard treatment of surgery and postoperative adjuvant therapy. The neoadjuvant TPF arm will received two cycles of intravenous Docetaxel (75mg/m^2), Cisplatin (75mg/m^2) on d1 (d22), and 5-Fu(750mg/m^2/day) for 5 days (d1-5 and d22-26), followed by the standard treatment of surgery and postoperative adjuvant therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab (anti-programmed death-1 inhibitor)Drug
The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle.
Albumin paclitaxelDrug
The participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle.
CisplatinDrug
The participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle.
DocetaxelDrug
The participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m^2 of Docetaxel will be used intravenously on the first day of each cycle.
5-FluorouracilDrug
The participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5.
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant TTP | Experimental | The participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22. Receives: Drug: Toripalimab (anti-programmed death-1 inhibitor); Drug: Albumin paclitaxel; Drug: Cisplatin |
| Neoadjuvant TPF | Active comparator | The participants will receive two cycles of intravenous Docetaxel (75 mg/m^2) on d1 and d22, Cisplatin (75 mg/m^2) on d1 and d22, and 5-Fluorouracil (750 mg/m^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days. Receives: Drug: Cisplatin; Drug: Docetaxel; Drug: 5-Fluorouracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major pathologic response
The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.
Measured: 3 months
Secondary outcomes (2)
2-year disease-free survival rate
Disease-free survival was calculated from the date of randomization to tumor recurrence or death from any cause.
Measured: 24 months
2-year overall survival rate
Overall survival was calculated from the date of randomization to death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start1 Oct 2021
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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 Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05125055
- Sponsor's protocol ID
- Illuminate-2
- Status last verified
- Nov 2023
- First submitted
- 17 Nov 2021
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol and the primary study report might be shared depending on the condition of trial completion.
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 Albumin Paclitaxel /Cisplatin Versus Docetaxel/ Cisplatin/ 5-fluorouracil (TPF) on Pathological Response in Patients With Locally Advanced and Resectable Oral Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT05125055
- Acronym / sponsor ID
- Illuminate-2
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 18 Nov 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.
To compare the pathological efficacy of neoadjuvant Toripalimab and Albumin paclitaxel /Cisplatin (TTP) with Docetaxel/ Cisplatin/ 5-flurouracil (TPF) for patients with locally advanced resectable oral squamous cell carcinoma (OSCC), and to determine the safety of neoadjuvant TTP. In order to explore a better protocol of neoadjuvant therapy to improve the efficacy in patients with locally advanced OSCC.
Detailed description
In the previous "Illuminate" trial, neoadjuvant anti-programmed death-1 (PD-1) of Toripalimab and Albumin paclitaxel /Cisplatin (TTP) therapy was used in 20 patients with locally advanced and resectable oral squamous cell carcinoma (OSCC), and the neoadjuvant therapy was well-tolerated. The major pathologic response (MPR) rate was 60% (12/20), including 30% (6/20) pathological complete response (pCR). Furthermore, the MPR might transfer to survival benefit in the patients received neoadjuvant therapy. Therefore, in this randomized trial, we aimed to compare the pathological response of neoadjuvant TTP therapy versus TPF chemotherapy in the patients with locally advanced OSCC (Illuminate-2 trial). A total of 80 patients will be enrolled in this trial, and the primary endpoint is MPR rate. The neoadjuvant TTP arm will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD1 inhibitor, 240 mg) on d1 and d22, followed by the standard treatment of surgery and postoperative adjuvant therapy. The neoadjuvant TPF arm will received two cycles of intravenous Docetaxel (75mg/m^2), Cisplatin (75mg/m^2) on d1 (d22), and 5-Fu(750mg/m^2/day) for 5 days (d1-5 and d22-26), followed by the standard treatment of surgery and postoperative adjuvant therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant TTP | Experimental | Drug: Toripalimab (anti-programmed death-1 inhibitor), Drug: Albumin paclitaxel, Drug: CisplatinThe participants will receive two cycles of intravenous Albumin paclitaxel (260mg/ m^2), Cisplatin (75mg/ m^2) and Toripalimab (anti-PD-1 inhibitor, 240 mg) on d1 and d22. |
| Neoadjuvant TPF | Active comparator | Drug: Cisplatin, Drug: Docetaxel, Drug: 5-FluorouracilThe participants will receive two cycles of intravenous Docetaxel (75 mg/m^2) on d1 and d22, Cisplatin (75 mg/m^2) on d1 and d22, and 5-Fluorouracil (750 mg/m^2/day) for 5 days (d1-5 and d22-26), the interval is 16±1 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18-75 years old
- Gender: male and female
- Eastern Cooperative Oncology Group (ECOG) performance status (PS): 0-2
- Histopathological diagnosis of oral squamous cell carcinoma (including tongue, gums, cheek, floor of mouth, hard palate, and posterior molar region)
- Primary tumor with a clinical stage of III/IVA (T1-2/N1-2/M0 or T3-4a/cN0-2/M0, AJCC2018)
Key exclusion criteria (13 listed)
- Unresolved grade 2 [(Common Terminology Criteria for Adverse Events (CTCAE 5.0)] or higher toxic reactions caused by previous anticancer treatments
- Known allergic reaction to any ingredients or excipients of the therapy
- Known history of malignancy, unless been cured and no recurrence for 5 years
- Known history of radiation to head and neck
- Active severe clinical infection (> National Cancer Institute (NCI)-CTCAE version 5.0 grade 2 infection)
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 |
|---|---|---|
| Toripalimab (anti-programmed death-1 inhibitor)The participants will receive two cycles of Toripalimab, with 21 days each. 240mg of Toripalimab will be used intravenously on the first day of each cycle. | Drug | Neoadjuvant TTP |
| Albumin paclitaxelThe participants will receive two cycles of Albumin paclitaxel, with 21 days each. 260mg/m^2 of Albumin paclitaxel will be used intravenously on the first day of each cycle. | Drug | Neoadjuvant TTP |
| CisplatinThe participants will receive two cycles of Cisplatin, with 21 days each. 75mg/m^2 of Cisplatin will be used intravenously on the first day of each cycle. | Drug | Neoadjuvant TPF, Neoadjuvant TTP |
| DocetaxelThe participants will receive two cycles of Docetaxel, with 21 days each. 75mg/m^2 of Docetaxel will be used intravenously on the first day of each cycle. | Drug | Neoadjuvant TPF |
| 5-FluorouracilThe participants will receive two cycles of 5-Fluorouracil, with 21 days each. 750mg/m^2/d of 5-Fluorouracil will be used as a 120-hour continuous intravenous infusion on days 1 through 5. | Drug | Neoadjuvant TPF |
Primary outcome
Major pathologic response
Time frame: 3 months
The major pathologic response (MPR): the percentage of tumor cells before and after treatment was compared according to biopsy specimens before neoadjuvant therapy and pathological specimens after surgery; the percentage of residual viable tumor (RVT) cells was evaluated on resected tumor slides. MPR was defined as ≤ 10% RVT%.
2 secondary outcomes
2-year disease-free survival rate
Time frame: 24 months
2-year overall survival rate
Time frame: 24 months
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 22 Nov 2023.
- Individual participant dataSharing planned: Yes. The study protocol and the primary study report might be shared depending on the condition of trial completion.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Toripalimab (anti-programmed death-1 inhibitor), Albumin paclitaxel and Cisplatin in people with Oral Squamous Cell Carcinoma and Neoadjvant Therapy, 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 11 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 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Lai-ping Zhong, MD, PhD (+862123271699 ext. 5160, zhonglp@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major pathologic response (time frame: 3 months). 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 22 Nov 2023.