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Hypopharyngeal CarcinomaPhase 2NCT04156698

Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

A Phase 2 study testing Docetaxel, Cisplatin and Capecitabine in people with Hypopharyngeal Carcinoma and Immunotherapy, run by Eye & ENT Hospital of Fudan University 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 The sponsor has not verified this record for over two years, so it may be out of date.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 is a single-center, multidisciplinary, open-label, single-arm prospective clinical study. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Docetaxel, Cisplatin and Capecitabine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
21 May 2020to 16 Jan 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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients have histologically confirmed hypopharyngeal squamous cell carcinoma and require total laryngectomy, including the piriform fossa, postcricoid region, and posterior pharyngeal wall with TNM stage cT3-4aN0-2M0(AJCC 7th).
  • Able to understand and willing to sign a written informed consent document.
  • Age≥ 18 and≤ 70 years.
  • Male or female.
  • Performance status of ECOG 0-2.
  • Expected lifetime > 6 months.
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  • Normal blood test, hepatic and renal functions. Normal hearing. Blood test: WBC≥4.0×109/L，ANC≥2.0×109/L，PLT≥100×109/L，HGB≥100g/L；Hepatic function: ALT、AST< upper limit of normal. Kidney function: Serum creatinine < upper limit of normal value, and creatinine clearance rate ≥ 60 ml/min（Cockcroft-Gault formula）. Cardiac ultrasonography left ventricular ejection fraction >50%.
  • No prior allergic reaction to biological agents and/or ingredient in the drug.
  • No drug abuse.
  • Good compliance.
  • No other important related diseases (such as other tumors, severe heart, lung and central nervous system diseases, etc.).
  • Negative pregnancy test (for female patients with fertility).
  • Male patients with fertility and female patients with fertility and pregnancy risk must agree to use contraceptive methods throughout the study period, and continued until at least 6 months after the last dose of cisplatin and 30 days after the last dose of PD-1 antibody/placebo (whichever occurs later). Female patients who do not have fertility (ie meet at least one of the following criteria): Have undergone hysterectomy and/or bilateral oophorectomy with archival records, medically confirmed ovarian function decline; In postmenopausal state. It is defined as: At least 12 months of continuous menstruation without other pathological or physiological reasons, and the status confirmed by serum follicle stimulating hormone (FSH) levels is consistent with postmenopausal status.

Who cannot join

  • Patients with cervical lymph node cN3.
  • Have a history of other cancers in the past five years, radical or untreated prostate cancer (Gleason score ≤ 6), or complete treatment of breast ductal carcinoma in situ, except for patients with cured skin basal cell carcinoma or squamous cell skin cancer.
  • Patients with target lesions who have received radiation therapy or surgery (except biopsy).
  • Patients who have previously used chemotherapy, immunotherapy, or biological targeted therapy for primary tumors
  • Patients who have participated in other clinical trials within 4 weeks before the test.
  • Any of the following conditions in the first 6 months of random grouping: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, patients with transient ischemic attack or symptomatic pulmonary embolism.
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  • Patients with hypertension who cannot control well through single antihypertensive medication (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg);
  • Patients with grade I or above coronary heart disease, arrhythmia (including men with a QTc interval >450 ms, women >470 ms), and cardiac insufficiency.
  • Urinary protein was greater than ++ and 24-hour urinary protein quantification >1.0 g.
  • Many factors that affect oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction).
  • Patients with abnormal coagulation function（INR>1.5、APTT>1.5 ULN）and bleeding tendency.
  • Patients with a history of psychotropic substance abuse that is active or has a mental disorder.
  • Patients who required systemic treatment with corticosteroids (>10 mg prednisone equivalent daily) or other immunosuppressive agents within 2 weeks prior to the first use of the study drug.
  • Patients with a history of severe allergies or allergies; patients with active autoimmune diseases that may worsen when receiving immunostimulants; patients with type 1 diabetes, vitiligo, psoriasis, or hypothyroidism or hyperthyroidism who do not require immunosuppressive therapy are eligible to participate in the study.
  • Patients who have previously been diagnosed with immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (HBV) surface antigen is positive at screening, or patients with positive HCV RNA [ribonucleic acid] when positive for anti-HCV antibody screening test.
  • Vaccination within 4 weeks prior to randomization, except for inactivated vaccines.
  • Pregnant or lactating women who are in the reproductive period but have not taken effective contraceptive measures.
  • The investigator believes that it is inappropriate for individuals to participate in the trial: having, for example, severe acute or chronic medical conditions (including immune colitis, inflammatory bowel disease, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including recent time [within the past year] or active suicidal ideation or behavior) .
  • With a history of tuberculosis or antituberculosis treatment.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Eye & ENT Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200031

Other trials in China

About this study

Official title: A Phase II, Single-center, Open-label, Single-arm Study of Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.

Read the detailed description

In this study, 51 patients with hypohparyngeal carcinoma will be enrolled, These patients who have locally advanced-stage disease, including TNM stage cT3-4aN0-2M0 (AJCC 7th) and require a total laryngectomy as an initial therapy. Patients who achieved a CR or PR at the primary site after three cycles of TPF-regimen chemotherapy combined with immuotherapy will be referred for definitive RT and immuotherapy, while patients who received an evaluation of PD or SD at the primary site were referred for surgery followed by adjuvant RT/CRT.

Keywords
Locally advanced hypopharyngeal squamous cell carcinoma, Programmed death protein - 1 inhibitor, Camrelizumab, Objective response rate, Safety profiles
Medical subject headings
Hypopharyngeal Neoplasms

What participants receive

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

  • DocetaxelDrug

    Also called Docetaxel (domestic)

    Docetaxel is a chemotherapy drug.

  • CisplatinDrug

    Also called chemotherapy drug

    Cisplatin is a chemotherapy drug.

  • CapecitabineDrug

    Also called chemotherapy drug

    Capecitabine is a chemotherapy drug.

  • CamrelizumabDrug

    Also called Anti-PD-1 Antibody (Jiangsu Hengrui)

    Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Study groups in NCT04156698
Study groupRoleWhat they receive
Camrelizumab (PD-1 inhibitor) groupExperimentalInduction chemotherapy combined with immunotherapy (TPF + Camrelizumab), q3w, 3 cycles in total: Docetaxel (domestic) 75 mg/m2 i.v. d1, Cisplatin 25 mg/m2 i.v. d1-3, Capecitabine 800 mg/m2 po bid d1-d14, Camrelizumab 200mg i.v. d1; Radical radiotherapy plus concurrent immunotherapy (CR or PR): Radiotherapy: Using intensity-modulated radiation therapy (IMRT). Primary site: GTV dose 66 (2.2Gy / fraction)-70 Gy (2Gy / fraction)；CTV 1.6-1.9 Gy / fraction. Cervical lymph nodes: Radiotherapy plan is the same as the radiotherapy plan of original site; Concurrent immunotherapy : Camrelizumab 200mg i.v. d1, d22; Maintenance period: After completing concurrent chemoradiotherapy combined with immunotherapy, Camrelizumab 200 mg q3w will be given up to 12 months (calculated from the time of the first dose of PD-1 immunotherapy).
Receives: Drug: Docetaxel; Drug: Cisplatin; Drug: Capecitabine; Drug: Camrelizumab

What is being measured

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

  1. Overall Response Rate

    The proportion of patients with partial and complete response as defined by RECIST 1.1 after induction therapy

    Measured: 9 weeks

Secondary outcomes (4)

  1. LPR

    Larynx preservation rate

    Measured: 3 years

  2. PFS

    Progression free survival

    Measured: 3 years

  3. MFS

    Metastasis free survival

    Measured: 3 years

  4. OS

    Overall survival

    Measured: 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 posted7 Nov 2019
  2. Study start21 May 2020
  3. Primary completion16 Apr 2023
  4. Study completion16 Jan 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
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04156698
Sponsor's protocol ID
zhouliang
Status last verified
Aug 2023
First submitted
6 Nov 2019
Last updated
9 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 Docetaxel, Cisplatin and Capecitabine in people with Hypopharyngeal Carcinoma and Immunotherapy, run by Eye & ENT Hospital of Fudan University 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 13 inclusion and 19 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 9 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?

Results are not available in the source record.

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?

Overall Response Rate (time frame: 9 weeks). 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 NCT04156698.

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 9 Aug 2023.

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