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Oral Squamous Cell CarcinomaPhase 2NCT05803915

Neoadjuvant Toripalimab Plus Nimotuzumab in Oral Squamous Cell Carcinoma Prior to Radical Therapy

A Phase 2 study testing Toripalimab in people with Oral Squamous Cell Carcinoma, run by Peking Union Medical College Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study aims to investigate the efficacy and safety of neoadjuvant Toripalimab combined with Nimotuzumab in primary limited stage oral squamous cell carcinoma prior to radical therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Oral Squamous Cell Carcinoma
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
57 participants
Where
1 siteChina
Study dates
1 May 2023to 10 Mar 2026
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

  • Aged ≥18 years old；male or female.
  • Oral squamous cell carcinoma confirmed by cytology or histology. Evaluation by the investigators to confirmed primary limited-stage (clinical stage T1N+M0, T2-4 anyNM0, AJCC 8th) without prior treatment.
  • Patients who are suitable and agree radical therapy.
  • At least 1 evaluable lesion according to RECIST v1.1.
  • ECOG PS ≤ 1
  • Adequate organ function, defined as achieving the following laboratory test results ≤ 14 days before treatment
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  • Patients must meet the following laboratory test results: i. ANC ≥ 1.5 x 10^9 / L ii. Platelets ≥100 x 10^9 / L iii. Hb ≥90 g / L Note: Patients must not receive blood transfusion or growth factor within 14 days before blood sample collection due to neutrophil count, platelet, or hemoglobin below study requirements.
  • Renal function requirements within 4 weeks before treatment: Endogenous creatinine clearance ≥ 60 mL / min or more (based on 24-hour urine creatinine calculation or Cockcroft-Gault formula method).
  • Serum total bilirubin ≤ 1.5×ULN (Gilbert syndrome patients can be enrolled if the total bilirubin is <3 × ULN).
  • AST and ALT ≤ 3 × ULN. If the patient has liver metastases, AST and ALT ≤ 5×ULN
  • Patients with hepatitis B virus (HBV) infection and inactive / asymptomatic HBV carriers; or patients with chronic or active HBV, if HBV DNA <500 IU / mL (or 2500 copies/ mL) will be allowed to enroll. Hepatitis C antibody-positive patients will be allowed to enroll if HCV-RNA is negative during screening.
  • NOTE: Patients with detect hepatitis B surface antigen (HBsAg) or HBV DNA, and patients receiving antiviral therapy during screening should be treated for> 2 weeks before enrollment, and Continue treatment for 6 months after study drug therapy
  • Women of childbearing age (WOCBP) must be willing to take effective contraception during the study period and ≥60 days after the last study treatment (including chemotherapy) administration, and the urine or serum pregnancy test result is negative within ≤7 days before treatment.
  • Women of childbearing age are defined as any woman who has had menarche and has not undergone sterilization (hysterectomy or bilateral ovariectomy) and has not yet reached menopause. Menopause is defined as amenorrhea for 12 months in women> 45 without other biological or physiological causes. In addition, to confirm menopause, women under 55 must have serum follicle stimulating hormone (FSH) levels> 40 mIU / mL.
  • Unsterilized male must be willing to take effective contraception during the study and ≥ 60 days after the last study treatment (including chemotherapy) was administered.

Who cannot join

  • Not suitable for toripalimab or nimotuzumab treatment.
  • Have previously received any treatment for oral squamous cell carcinoma.
  • Patients with evidence of fistula (esophagus / bronchus or esophagus / aorta)
  • Presence of uncontrollable pleural effusion, pericardial effusion, or ascites that require repeated drainage or medical intervention (with clinically significant recurrence requiring additional intervention within 2 weeks after the intervention).
  • Evidence of complete esophageal obstruction that is not suitable for treatment
  • Have been treated with antitumor agents targeted to PD-1, PD-L1 or PD-L2.
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  • Have active meningeal disease or uncontrolled brain metastases.
  • Patients with active autoimmune disease or history of autoimmune diseases may relapse.
  • Note: Patients with the following diseases can be entered for further screening:
  • Controllable type 1 diabetes
  • Hypothyroidism (only if it could be controlled by hormone replacement therapy)
  • Controlled celiac disease
  • Skin diseases that do not require systemic treatment (eg vitiligo, psoriasis, hair loss)
  • Any other disease that is not expected to recur without external triggers
  • Any active malignancy within ≤ 2 years before treatment, expect specific cancers which being studied in this study and locally recurrent cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical cancer and breast cancer in situ).
  • Any condition requiring systemic treatment with corticosteroids (dose above 10 mg / day of prednisone or equivalent dose of similar agents) or other immunosuppressive agents within ≤ 14 days prior to treatment.
  • Note: Patients who are currently or previously using any of the following steroid regimens can be enrolled:
  • Adrenaline replacement (prednisone ≤10mg / day or equivalent dose of similar agents)
  • Local, ophthalmic, intra-articular, intranasal, and inhaled corticosteroids with minimal systemic absorption.
  • Prophylactic short-term (≤7 days) use of corticosteroids (for example, to prevent hypersensitivity caused by contrast agent) or to treat non-autoimmune conditions (for example, delayed-type hypersensitivity reactions caused by exposure to allergens).
  • Have a history of interstitial lung disease, non-infectious pneumonia or uncontrolled disease including pulmonary fibrosis, acute lung disease, etc.
  • Severe chronic or active infections (including tuberculosis infections, etc.) that require systemic antibacterial, antifungal, or antiviral treatment within 14 days of treatment.
  • History of HIV infection.
  • Underwent any major surgery requiring general anesthesia ≤ 28 days before treatment.
  • Previously allogeneic stem cell transplantation or organ transplantation.
  • Have any of the following cardiovascular risk factors:
  • Cardiogenic chest pain occurs within ≤ 28 days prior to treatment and is defined as moderate pain that limits applianceal activities of daily life.
  • Symptomatic pulmonary embolism occurred within ≤ 28 days before treatment
  • Acute myocardial infarction occurred within 6 months before treatment
  • History of heart failure that has reached New York Heart Association Class III or IV ≤ 6 months before treatment.
  • Ventricular arrhythmia of grade ≥ 2 occurred within ≤ 6 months before treatment
  • Cerebrovascular accident occurred within ≤ 6 months before treatment
  • Uncontrolled hypertension: SBP ≥160 mmHg or DBP ≥100 mmHg, although antihypertensive drugs were used ≤ 28 days before treatment or before the first study drug
  • Any syncope or convulsions ≤ 28 days before treatment
  • History of severe hypersensitivity to other monoclonal antibodies.
  • Have received Chinese herbal medicine or proprietary Chinese medicine for cancer control within 14 days before the first study drug administration.
  • Live vaccinations within ≤ 4 weeks before treatment. Note: Seasonal flu vaccines are usually inactivated vaccines and are allowed. The vaccine used in the nasal cavity is a live vaccine and is not allowed.
  • Presence of basic medical conditions (including abnormal laboratory test values) or alcohol / drug abuse or dependence that are detrimental to study drug administration or affect drug toxicity or AE interpretation, or that may reduce compliance during the study .
  • Participate in another clinical trial at the same time
  • Unintentional weight loss ≥ 5% within 1 month before treatment or severe malnutrition.
  • Nutritional risk index (Shirasu et al 2018) can be used to determine severe malnutrition
  • Pregnant or lactating women
  • Peripheral neuropathy ≥ grade 2 at baseline
  • Uncontrolled diabetes, abnormalities of laboratory tests in potassium, sodium or corrected calcium>grade 1 despite standard medication，or hypoalbuminemia ≥ grade 3 within 14 days before treatment.
  • Have received any chemotherapy, immunotherapy (eg interleukin, interferon, thymosin) or any research treatment within 14 days or 5 half-lives (whichever is longer) before the first study drug administration.
  • Other exclusion criteria
  • Prisoner or jailer.
  • People who have been compulsorily detained for the treatment of a mental or physical illness, such as an infectious disease.

Trial locations and contacts

1 site in 1 country.

Ning Jia contact

13161312858

doctorjn@163.com

China1 site

  • Peking Union Medical College Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing, 100730

    Ning Jia

    Jia Ning

Other trials in China

About this study

Official title: Neoadjuvant Toripalimab Plus Nimotuzumab in Primary Limited-Stage Oral Squamous Cell Carcinoma Prior to Radical Therapy：A Single-arm, Phase Ⅱ Study

This study aims to investigate the efficacy and safety of neoadjuvant Toripalimab combined with Nimotuzumab in primary limited stage oral squamous cell carcinoma prior to radical therapy.

Read the detailed description

The purpose of this study is to investigate the efficacy and safety of neoadjuvant PD-1 inhibitor toripalimab plus nimotuzumab in subjects with primary limited stage, oral squamous cell carcinoma prior to radical therapy. Patients would be treated with neoadjuvant toripalimab plus nimotuzumab for 2 cycles and then received radical surgery or radiotherapy based on the efficacy assessed by investigators per RECIST v1.1.

Being tested
Toripalimab
Keywords
Oral Squamous Cell Carcinoma, Toripalimab, Neoadjuvant, PD-1 inhibitor
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.

  • ToripalimabDrug

    Also called JS001

    The participants will receive Toripalimab 240mg intravenous infusion every 3 week, and Nimotuzumab 150mg/㎡ every 2 week for 2 cycles

Study groups in NCT05803915
Study groupRoleWhat they receive
Neoadjuvant Toripalimab plus NimotuzumabExperimentalThe participants will receive 2 doses of neoadjuvant Toripalimab plus Nimotuzumab, then the participants will take a radical surgery or radiotherapy according to the efficacy assessed by investigator per RECIST1.1
Receives: Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathologic response (MPR) rate

    MPR rate is defined as the proportion of participants who have achieved major pathological response（on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy and underwent surgery.

    Measured: up to 18 months

Secondary outcomes (7)

  1. Objective response rate (ORR)

    ORR is defined as the percentage of participants having a complete response or partial response (according to RECIST v1.1) as confirmed by CT or MRI evaluation in all patients who have completed the neoadjuvant therapy.

    Measured: up to 18 months

  2. 2-year disease-free survival rate (DFS)

    DFS is defined as the time from the first day of randomization to the date of first record of disease recurrence or death after radical treatment

    Measured: up to 42 months

  3. 2-year progression-free survival rate (PFS)

    PFS is defined as the time from the first day of randomization to the date of first record of disease progression or death.

    Measured: up to 42 months

  4. 2-year overall survival rate (OS)

    OS is defined as the time from randomization to death due to any cause.

    Measured: up to 42 months

  5. Change in PD-L1 expression

    Change in the expression of PD-L1 in the tumor tissues from before and after neoadjuvant therapy, based on quantification using immunohistochemistry (IHC) and image analysis.

    Measured: up to 42 months

  6. QoL scores as evaluated by EORTC H&N 35.

    QoL scores as evaluated the quality of life by EORTC H\&N 35.

    Measured: up to 42 months

  7. Incidence and severity of adverse events as evaluated by NCI-CTCAEv5.0.

    Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions associated with the experimental interventions

    Measured: up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start1 May 2023 (estimated)
  3. Primary completion30 Sep 2024 (estimated)
  4. Study completion10 Mar 2026 (estimated)

Resources

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
57 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05803915
Sponsor's protocol ID
JS001-ISS-CO407
Status last verified
Feb 2023
First submitted
28 Feb 2023
Last updated
7 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Toripalimab in people with Oral Squamous Cell Carcinoma, run by Peking Union Medical College Hospital 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 15 inclusion and 48 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 7 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 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 Ning Jia (13161312858, doctorjn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathologic response (MPR) rate (time frame: up to 18 months). 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 NCT05803915.

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 7 Apr 2023.

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