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Hypopharyngeal Squamous Cell CarcinomaPhase 2NCT04296747

Toripalimab in Combination With Chemotherapy as Induced Chemotherapy for Localized Hypopharyngeal Cancer

A Phase 2 study testing induction chemotherapy, surgery and chemoradiotherapy in people with Hypopharyngeal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypopharyngeal Squamous Cell Carcinoma
What is being tested?
induction chemotherapy, surgery and chemoradiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Mar 2020to Mar 2023
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

  • Age ≥ 18 years when signing informed consent.
  • Pathopharyngeal (histological) confirmed hypopharyngeal squamous cell carcinoma.
  • The initial diagnosis is T1N + M0, T2-4 anyNM0 according to the 8th edition of AJCC.
  • Patients who is suitable and agrees to radical treatment.
  • With evaluable lesions according to the RECIST version 1.1. Note: According to the RECIST 1.1, evaluable lesions refers to a lesion that has been previously treated with radiotherapy. If a clear tumor progression appearance then, it can be used as a measurable lesion.
  • ECOG PS ≤1
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  • Adequate organ function, defined as achieving the following laboratory test results ≤ 14 days before treatment
  • Patients must meet the following laboratory test results: i. ANC ≥ 1.5 x 109 / L ii. Platelets ≥100 x 109 / 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 any of the two-drug chemotherapy prescribed in the protocol
  • Have previously received any treatment for hypopharyngeal 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 a history of CNS metastasis while be asymptomatic at the time of screening can be recruit as long as they meet all the following conditions: i. Patients without immediate radiological progression, which means disease progression happened between two consecutive assessments (1 month interval) ii. There are evaluable lesions outside CNS. iii. No need for continuous use of glucocorticoids to treat CNS disease; stable doses of anticonvulsants would be allowed.
  • No stereotactic or whole brain radiotherapy was performed within 14 days before treatment.
  • Patients with new asymptomatic CNS metastases that need to be treated with radiation and / or surgery and have completed corticosteroid therapy.
  • After treatment, these patients are eligible as long as they meet all other criteria, including those with 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 therapeutic 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

No sites are listed yet.

Chunmei Bai, doctor contact

8601069156114 ext. 8601069156114

baichunmei1964@163.com

About this study

Official title: A Single-arm Study Evaluating Efficacy and Safety of Toripalimab Combined With Docetaxel and Cisplatin as Induced Chemotherapy in the Treatment of Localized Hypopharyngeal Squamous Cell Carcinoma

60% of hypopharyngeal cancers were locally advanced at the time of diagnosis. The standard treatment was surgery and postoperative radiotherapy. Compared with traditional surgery and postoperative radiotherapy, induction chemotherapy combined with radiotherapy has a better laryngeal retention rate without reducing the curative effect, and established an organ function preservation treatment strategy. Induction chemotherapy can reduce tumor burden and reduce distant metastases. At present, induction chemotherapy followed by concurrent chemoradiotherapy has become the standard treatment for the laryngeal preservation in locally advanced hypopharyngeal and laryngeal cancer. This study aimed to investigate the efficacy and safety of a PD-1 inhibitor toripalimab combined with chemotherapy as induction therapy in hypopharyngeal cancer.

Read the detailed description

This is a phase II, multicenter, open-label, single-arm study, planned to enroll 100 patients with localized hypopharyngeal squamous cell carcinoma who are newly treated and could accept radical treatment. Patients would be treated with toripalimab combined with docetaxel and cisplatin for two cycles. After the induction chemotherapy is completed, the investigator choose appropriate radical treatment (surgery or chemoradiotherapy) based on tumor evaluation. The primary endpoint is overall objective rate (ORR), the second endpoint include major pathologic response (MPR), 2-year DFS for surgery patients, 2-year PFS for radiotherapy patients, OS and QOL.

Being tested
induction chemotherapy, surgery, chemoradiotherapy
Keywords
Toripalimab, hypopharyngeal cancer, induction therapy
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Hypopharyngeal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • induction chemotherapyDrug

    Toripalimab 240mg, d1; docetaxel 75mg/m2 d1; cisplatin 75mg/m2 d1, q21d, for 2 cycles

  • surgeryProcedure or surgery

    After induction chemotherapy, patients with resectable hypopharyngeal cancer would accept surgery within 2-4 weeks and investigator-selected postoperative treatment

  • chemoradiotherapyRadiation

    After induction chemotherapy, patients with unresectable hypopharyngeal cancer who achieved CR/PR/SD in the tumor evaluation according to RECIST1.1 would accept another cycle of chemotherapy, and then radical chemoradiotherapy with cisplatin 100mg/m2, q21d

Study groups in NCT04296747
Study groupRoleWhat they receive
Induction therapyExperimentalpatients would accept toripalimab combined with chemotherapy as induction therapy, then radical treatment(surgery or chemoradiotherapy) according to whether the tumor could be resectable or the evaluation result according to RECIST1.1. Ones with PD after induction therapy will enter survival follow-up directly
Receives: Drug: induction chemotherapy; Procedure: surgery; Radiation: chemoradiotherapy

What is being measured

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

  1. overall objective rate

    the percentage of patients whose best overall response was confirmed complete or partial response

    Measured: Up to 2 year

Secondary outcomes (5)

  1. major pathologic response

    the percentage of patients whose postoperative pathology showing surviving tumor cells ≤10%

    Measured: Up to 2 year

  2. 2-year overall survival rate

    the percentage of patients who survived at 2 year from the first dose

    Measured: Up to 2 years

  3. 2-year progression-free survival rate

    the percentage of patients who accepted chemoradiotherapy and survived without initial radiological progression or death from any cause at 2 year from the first dose

    Measured: Up to 2 years

  4. 2-year disease-free survival rate

    the percentage of patients who accepted surgery and survived without the first appearance of disease or death from any cause at 2 year from the first dose

    Measured: Up to 2 years

  5. EORTC H&N 35 form evaluated quality of life

    EORTC H\&N 35 form evaluated quality of life

    Measured: Up to 2 years

Timeline

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

  1. First posted5 Mar 2020
  2. Study startMar 2020 (estimated)
  3. Primary completionMar 2022 (estimated)
  4. Study completionMar 2023 (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
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04296747
Sponsor's protocol ID
JS001-ISS-CO159
Status last verified
Feb 2020
First submitted
3 Mar 2020
Last updated
5 Mar 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing induction chemotherapy, surgery and chemoradiotherapy in people with Hypopharyngeal Squamous Cell Carcinoma, run by Peking Union Medical College Hospital.

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 17 inclusion and 52 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 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

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 Chunmei Bai, doctor (8601069156114 ext. 8601069156114, baichunmei1964@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall objective rate (time frame: Up to 2 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 NCT04296747.

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 5 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.

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