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Head and Neck Squamous Cell CarcinomaPhase 2PC-1NCT05993858

Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced HNSCC

A Phase 2 study testing 3cycles (Toripalimab + cetuximab), Surgery and Radiotherapy or chemoradiotherapy in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a single-center, single-arm, phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
3cycles (Toripalimab + cetuximab), Surgery and Radiotherapy or chemoradiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
1 siteChina
Study dates
20 Oct 2023to 20 Dec 2026
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

  • The age at the time of enrollment is more than 18 years old and less than 70 years old, both male and female.
  • Histologically diagnosed as squamous cell carcinoma of the mouth, oropharynx, hypopharynx or larynx; preoperative evaluation can be surgically resected.
  • Have the following high-risk recurrence conditions as defined in the 8th edition of the American Joint Committee on Cancer [AJCC] Guidelines: a)HPV-negative disease, stage III, IVa, according to the head and Neck Tumor/lymph node/metastasis (TNM) guidelines; b)non-oropharyngeal HPV-positive disease, stages III, IVa, IVb, according to head and neck TNM guidelines.
  • No previous treatment for HNSCC.
  • Have at least one evaluable target lesion according to RECIST version 1.1 criteria.
  • The Eastern Cancer Cooperation Organization (ECOG) physical fitness score was 0 or 1.
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  • Major organs have normal function, the following criteria are met:
  • The standard of blood routine examination（(not transfused or receiving component blood within 14 days prior to testing)：hemoglobin (HB) ≥ 9g/dL；absolute neutrophil count (ANC) ≥1.5×10^9/L, platelets (PLT) ≥100×10^9/L.
  • Biochemical examination: serum total bilirubin (TBIL) <1.5 times the upper limit of normal value(ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<2.5 ULN; serum creatinine≤ULN and endogenous creatinine clearance>50 mL/min (Cockcroft-Gault formula) Gault formula).
  • Signed written informed consent.
  • Adhere to the research protocol judged by the investigator.
  • female subjects of reproductive potential must have a negative serum pregnancy test prior to the first dose of the trial drug.
  • The male fertile patients and female fertile patients with pregnancy risk must consent to the use of 2 contraceptive methods (at least one of which is considered highly effective) throughout the study period.
  • Patients who are willing and able to follow visit schedules, treatment plans, laboratory tests, and other research procedures.

Who cannot join

  • prior treatment with EGFR/PD-1/PD-L1/PD-L2/CD137/CTLA-4 antibodies(including ipilimumab) or activating or inhibitory agents targeting T-cell receptors.
  • Major surgery within 4 weeks before enrollment.
  • Proven allergic to EGFR monoclonal antibody, PD-1 antibody or its excipients.
  • Any active autoimmune disease or history of autoimmune disease (e.g., the following: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after effective hormone replacement therapy), etc; patients with vitiligo or asthma in complete remission in childhood may be included, adults patients with asthma who do not need any intervention and require medical intervention with bronchodilators may be included) .
  • Previous or co-existing malignancies (except those that have been cured and have survived cancer-free for more than 5 years, such as basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid).
  • Failure to control cardiac clinical symptoms or disease, e.g., the following: a) patients with NYHAII or above heart failure, b) unstable angina pectoris c) patients with myocardial infarction within 1 year, d) patients with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention.
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  • Subjects requiring systemic treatment with corticosteroids (> 10mg/ day prednisone efficacy dose) or other immunosuppressants within 14 days prior to administration of the study drug were allowed to use inhaled or topical steroids and adrenal hormone replacement at a dose>10mg/day prednisone efficacy dose in the absence of active autoimmune disease.
  • Have active infections that require treatment.
  • Have a congenital or acquired immune deficiency (such as HIV infection), active hepatitis B (HBV-DNA≥10^3 copy number/ml), or hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower detection limit of analytical methods).
  • The patient has received other treatment before.
  • Had received live vaccine within 4 weeks prior to starting study treatment.
  • A known history of psychotropic substance abuse, alcohol or drug use.
  • Pregnant or lactating women.
  • In the investigator's judgment, the subjects had other factors that might have led to their forced discontinuation of the study, such as other serious medical conditions (including mental illness) requiring concomitant treatment, serious abnormalities in laboratory test values, or family or social factors that might have affected the safety of the subjects or the circumstances of the trial data collection.
  • HNSCC Patients with T1/T2 or N0/N1.
  • oral cancer, larynx cancer, hypopharyngeal cancer withT4b or N3 and P16-oropharyngeal cancer.
  • Have active pulmonary tuberculosis.
  • Serious infections (including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia) that occurred within 4 weeks prior to initiation of study treatment.
  • Had received systemic immunostimulatory drugs (including but not limited to interferon or interleukin-2 [IL-2]) within 4 weeks prior to initiation of study therapy or remained within 5 drug half-lives (choice the longer of the two).
  • Patients with recurrent peptic ulcers (e.g., gastric ulcers, duodenal ulcers), who have a history of peptic ulcer complications such as perforation, bleeding, obstruction, etc., or who have been assessed by clinicians as having a higher risk of complications.

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

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hebei, 430000

    Kunyu Yang, Doctor, +86-13995595360, yangkunyu@hust.edu.cn

Other trials in China

About this study

Official title: A Single-Center, Single-Arm Exploratory Clinical Trial of Neoadjuvant PD-1 Inhibitor Combined With Cetuximab in Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

This is a single-center, single-arm, phase II clinical study to evaluate the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.

Read the detailed description

At present, the standard treatment for patients with operable locally advanced head and neck squamous cell carcinoma (HNSCC) is adjuvant radiotherapy with or without platinum-based synchronous chemotherapy after operation. However, the risk of recurrence, metastasis and death remains high in this population with this intense combination treatment regimen. Both EGFR monoclonal antibody and PD-1 inhibitors have proven the effect in advanced HNSCC. At the same time, cetuximab and PD-1 inhibitors have been reported to have a synergistic effect that may improve patient survival. This study aims to explore the efficacy and safety of PD-1 inhibitor combined with cetuximab in neoadjuvant therapy for locally advanced HNSCC.

Being tested
3cycles (Toripalimab + cetuximab), Surgery, Radiotherapy or chemoradiotherapy
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.

  • 3cycles (Toripalimab + cetuximab)Drug

    Toripalimab by intravenous (IV) infusion every 3 weeks (Q3W), 3 preoperative and 17 consolidated doses.

    The preoperative starting dose of cetuximab is 400 mg/m^2 by IV infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 9.

  • SurgeryProcedure or surgery

    After neoadjuvant therapy, patients would accept surgery within 11-13 weeks.

  • Radiotherapy or chemoradiotherapyRadiation

    Adjuvant radiotherapy was given 4 weeks after surgery. Patients with positive intraoperative pathological margins/extra lymph node envelope invasion are treated with an additional cisplatin synchronous chemotherapy.

Study groups in NCT05993858
Study groupRoleWhat they receive
Neoadjuvant therapy+Surgery+Adjuvant therapy+Consolidation therapyOtherParticipants receive totally 3 cycles of neoadjuvant therapy (Toripalimab+cetuximab), then radical treatment(surgery). After surgery, Participants receive radiotherapy or chemoradiotherapy according to the pathological results of the operation. Then, participants receive consolidation therapy of Toripalimab.
Receives: Drug: 3cycles (Toripalimab + cetuximab); Procedure: Surgery; Radiation: Radiotherapy or chemoradiotherapy

What is being measured

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

  1. Pathological Complete Response (pCR) Rate evaluated by investigators

    pCR rate is defined as the percentage of participants having an absence of residual invasive cancer in resected tumour and lymph nodes following completion of neoadjuvant therapy.

    Measured: up to 13 weeks after neoadjuvant

Secondary outcomes (6)

  1. 2 years Event-free survival (EFS) Rate evaluated by investigators

    Event Free Survival (EFS): EFS is defined as the time from randomization until radiographic disease progression, local progression precluding surgery, inability to resect the tumor, local or distant recurrence, or death due to any cause. The 2y-EFS rate is defined as the probability of event-free survival for a patient at a given point in time (2 years).

    Measured: EFS Up to 3 years

  2. Incidence of AEs/SAEs

    Overall incidence of adverse events (AEs); incidence of grade 3 and above AEs; incidence of serious adverse events (SAEs).

    Measured: Up to 3 years

  3. Objective Response Rate (ORR) evaluated by investigators

    The ORR was defined as proportion of patients whose tumor volume was reduced to 30% and sustained for more than 4 weeks as assessed by RECIST 1.1.

    Measured: Up to 3 years

  4. Major Pathological Response (MPR) Rate evaluated by investigators

    MPR rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes in neoadjuvant therapy.

    Measured: up to 13 weeks after neoadjuvant

  5. 2 years Disease-free survival (DFS) Rate evaluated by investigators

    DFS is defined as the time from postoperation until radiographic disease progression, local or distant recurrence, or death due to any cause. The 2y-DFS rate is defined as the probability of disease-free survival for a patient at a given point in time (2 years).

    Measured: DFS Up to 3 years

  6. Organ Retention Rate

    Organ retention rate is defined as the proportion of patients whose tumor avoids radical surgery.

    Measured: Up to 3 years

Timeline

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

  1. First posted15 Aug 2023
  2. Study start20 Oct 2023 (estimated)
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Dec 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
33 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05993858
Sponsor's protocol ID
UHCT230527
Acronym
PC-1
Status last verified
Jul 2023
First submitted
19 Jul 2023
Last updated
15 Aug 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 3cycles (Toripalimab + cetuximab), Surgery and Radiotherapy or chemoradiotherapy in people with Head and Neck Squamous Cell Carcinoma and Neoadjuvant Therapy, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 14 inclusion and 20 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: opening soon, as of the sponsor's last update on 15 Aug 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?

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pathological Complete Response (pCR) Rate evaluated by investigators (time frame: up to 13 weeks after neoadjuvant). 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 NCT05993858.

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 Aug 2023.

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