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Head and Neck Squamous Cell CarcinomaPhase 2HNSCCNCT05189184

Study of Camrelizumab in Combination With Apatinib Mesylate Plus Albumin-bound Paclitaxel and Cisplatin as the First Line Treatment of Recurrent or Metastatic, UnresectableHead and Neck Squamous Cell Carcinoma

A Phase 2 study testing Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

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 The sponsor has not verified this record for over two years, so it may be out of date.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 prospective, open-labelled study to evaluate the efficacy and safety of Camrelizumab in Combination With Apatinib mesylate Plus Albumin-bound paclitaxel and cisplatin as the First Line Treatment of Metastatic or Recurrent, UnresectableHead and Neck Squamous Cell Carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
No sites listed yet
Study dates
30 Mar 2022to 30 Mar 2025
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1、Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan; 2、Aged >=18 years; 3、Histologically confirmed recurrent or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies； 4、Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5、Expected survival period ≥ 3 months； 6、Tumor tissue with PD-L1 detection (paraffin specimens or fresh tumor tissue within 2 years) can be provided or PD-L1 test report of tumor tissue samples issued by a state-approved qualification unit； 7、At least one measurable lesion, according to RECIST 1.1; 8、Toxicity of the subject has been restored to the ≤1 level defined by NCI-CTCAE V5.0 (except hair loss)； 9、Patients must be able to swallow oral drugs and do not have significant affected gastrointestinal abnormalities, such as absorption adverse syndrome or most of the gastrointestinal tract; 10、The main function is normal, the test results at the time of screening must meet the following requirements:
  • Blood routine (no blood transfusion, erythropoietin (EPO), granulocyte-colony-stimulating factor (G-CSF) or granulocyte-macrophage-colony-stimulating factor (GM-CSF) within 14 days prior to screening) :
  • A.Hemoglobin (HB) ≥ 90 g / L; B.Absolute neutrophil count (ANC) of >= 1.510^9/L； C.platelet count of >= 10010^9/L；
  • Biochemical examination needs to meet the following criteria:
  • A.TBIL < 1.5 ULN (Gilbert syndrome patient, < 3 ULN); B.ALT and AST < 3 ULN, if there exists hepatic metastases, ALT and AST < 5 ULN； C.Cr <=1.5 ULN or CCr ≥50ml/min;
  • Echocardiography：LVEF≥50%；
  • INR or PT <= 1.5 ULN, APTT <=1.5 ULN； 11、Contraception: Women of childbearing age should agree to use effective contraception during the study and for 6 months after the end of the study; Negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating; Men who agreed to use contraception during the study period and for six months after the end of the study period.

Who cannot join

  • Those who are allergic to drug treatment;
  • Disease that is suitable for local therapy administered with curative intent；
  • Accept system chemotherapy, but does not include a circulation of a multi-mode treatment for chemotherapy for local advanced diseases (this treatment end time must be 6 months from the first test for the first test);
  • Patients with local advanced head and neck squamous cell carcinoma have completed multi-mode chemotherapy completed within 6 months of disease progression;
  • It has received immunotherapy for anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibody or targeted to T cell common stimulation or immunoction point pathway;
  • There have been any malignant tumors in five years, except for other malignant tumors,cervical in situ cancer, non-melanoma skin cancer or other tumors / cancer that passively treats for at least 5 years without disease;
Show all 17Show fewer
  • Anti-blood vessel treatment was received within 6 months before administration;
  • According to NCI CTCAEV5.0, there have been peripheral neuropathy ≥ 2;
  • Accompanied by known active central nervous system transfer (CNS) and / or cancer meningitis: Previously received brain transfer subjects can participate in research, premise is the clinical stability for at least 2 weeks, no new or expanded brains Transfer evidence, and 14 days before the drug administration, steroids were stopped 14 days. The stable brain transfer in this definition should be determined before the study of drugs for the first time. The invisible brain transfer subject (ie there is no nervous system symptoms, no corticosteroids, no lesions> 1.5 cm) can participate, but need to periodically perform brain imaging in the disease site;
  • It has not been recovered from any acute impact of past surgery, chemotherapy or radiotherapy, ie, the subject of ≤1 (NCI CTCAEV5.0) (except for external hair loss), if the nutritional state is stable, it is allowed to radiotherapy and / or surgery Produced chronic advanced toxicity (pharyngeal / throat, namely oral dry, speech, swallowing abnormal)；
  • Within 4 weeks or 4 weeks before the first administration, the anti-tumor drug treatment (such as chemotherapy, hormone therapy, immunotherapy, antibody treatment, radiotherapy, etc.), except for reducing pain on bones, except for bones;
  • It has received major surgery within the 4 weeks of the first administration or is expected to carry out major surgery during this study;
  • In the first 2 weeks or 2 weeks of the first administration, immunosuppressive drugs is required, and the following is eliminated:
  • intranasal, inhalation, external use steroids or local steroid injection (such as joint internal injection);
  • physiological doses of systemic corticosteroids (≤10 mg / connone or equivalent dose);
  • A short-term (≤7 days) use steroids to prevent or treat non-autoimmune allergic diseases; 14.、Subjects that are known to have active, or have a medical history and may relapse (such as systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid disease, Patients with multiple hardening, vascular, glomerulitis, etc.), or high risk (such as receiving organ transplantation require immunotherapy). However, the following patients are allowed to be incorporated: patients with type I diabetic patients with fixed doses; only the autoimmune thyroid dysfunction of hormone replacement treatment; skin disease (such as eczema, occupancy) without systemic treatment 10% or less ramp, no opaque symptoms of psoriasis, etc.); 15、15. There is a significant clinical cardiovascular disease, including but not limited to acute myocardial infarction within 6 months of the group, severe / unstable angina or coronary and bridge; congestive heart failure New York Heart Association (NYHA) ≥ 2 Level; arrhythmia (including QTC inter-male male ≥ 450 ms, female ≥ 470 ms); left ventricular ejection fraction (LVEF) <50%;
  • 16、Under anti-hypertension treatment, still uncontrolled hypertension, defined as: systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg; 17、Urinalysis shows urine protein ≥2+ or 24-hour protein quantity test shows urinary protein ≥1 g; 18、History of mental drug abuse and unable to quit or have mental disabilities; 19、Active or uncontrolled severe infection; 20、It is known that there is a history of liver disease, including but not limited to known moonitis virus (HBV) infection and HBV DNA positive (≥1 × 104 copy / ml); Hepatitis Hepatitis Virus infection (HCV) and HCV RNA positive (≥1 × 103copy / ml), or cirrhosis, etc .; 21、Patients with pulmonary fibrosis, interstitial pneumonia, dust lung, radioactive pneumonia, drug-based pneumonia and severe lung function; 22、Pregnancy (pregnancy detection of pregnancy) or women underwater; 23、The first use of medication within 30 days or expected to vaccinate the vaccination during the study; 24、Subjects have or plans to receive physical organs or blood system transplants during the study (except corneal transplantation); 25、According to the judgment of the researcher, it is considered that it is not suitable for the group.

About this study

This is a prospective, open-labelled study to evaluate the efficacy and safety of Camrelizumab in Combination With Apatinib mesylate Plus Albumin-bound paclitaxel and cisplatin as the First Line Treatment of Metastatic or Recurrent, UnresectableHead and Neck Squamous Cell Carcinoma. The objective response rate (ORR) will be evaluated as the primary endpoints.

Being tested
Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatin
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.

  • Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatinDrug

    Camrelizumab in Combination With Apatinib mesylate Plus Albumin-bound paclitaxel and cisplatin as the First Line Treatment of Recurrent or Metastatic , UnresectableHead and Neck Squamous Cell Carcinoma (HNSCC)

Study groups in NCT05189184
Study groupRoleWhat they receive
Study groupExperimentalInductive therapy with Camrelizumab and Apatinib Plus Albumin-bound paclitaxel and cisplatin
Receives: Drug: Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatin

What is being measured

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

  1. Objective Response Rate (CR+PR)

    Objective response rate (ORR) according to RECIST1.1

    Measured: Time Frame: Up to 24 months

Secondary outcomes (2)

  1. Overall survival (OS)

    Measured: Up to 24 months

  2. Progression free survival (PFS)

    Progression free survival (PFS) according to RECIST 1.1

    Measured: Up to 24 months

Timeline

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

  1. First posted12 Jan 2022
  2. Study start30 Mar 2022 (estimated)
  3. Primary completion30 Mar 2025 (estimated)
  4. Study completion30 Mar 2025 (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
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05189184
Sponsor's protocol ID
HNSCC-R/M-01
Acronym
HNSCC
Status last verified
Dec 2021
First submitted
29 Dec 2021
Last updated
12 Jan 2022
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 Camrelizumab+Apatinib mesylate+Albumin-bound paclitaxel+cisplatin in people with Head and Neck Squamous Cell Carcinoma, run by The First Affiliated Hospital of Zhengzhou University.

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 7 inclusion and 17 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 12 Jan 2022. 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?

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?

Objective Response Rate (CR+PR) (time frame: Time Frame: Up to 24 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 NCT05189184.

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 12 Jan 2022.

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