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Head and Neck CancerPhase 2NCT04922450

Clinical Study of Camrelizumab in Combination With Neoadjuvant Chemotherapy for Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

A Phase 2 study testing PD-1 inhibitor, Albumin Paclitaxel and Cisplatin in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Hunan Cancer 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In this single-arm study, pathologically confirmed advanced head and neck squamous cell carcinoma will be enrolled to investigate the efficacy and safety of Camrelizumab in combination With albumin paclitaxel and cisplatin. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Head and Neck Cancer, Squamous Cell Carcinoma
What is being tested?
PD-1 inhibitor, Albumin Paclitaxel and Cisplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
53 participants
Where
1 siteChina
Study dates
20 Jan 2021to 20 Jan 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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-65 years, both men and women;
  • Patients who diagnosed as Squamous cell carcinoma by pathological examination;
  • Patients who have not received systemic or local treatment for head and neck squamous cell carcinoma;
  • The primary tumor and lymph nodes can be completely surgically removed;
  • Exclude distant metastasis through chest CT and full-body bone scanning;
  • The patient's vital organs are functioning normally and can tolerate the specified treatment plan Absolute neutrophil count ≥1.8 × 109 / L platelets ≥100 × 109/L, Hemoglobin ≥9g/dL, serum albumin ≥3g/dL Bilirubin≤1.5 ULN ALT and AST≤2.5 ULN INR≤1.5 ULN leukocyte≥2000/L Serum creatinine ≤ 1.5 ULN Thyroid Stimulating Hormone≤ 1 ULN
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  • ECOG score：0-1
  • Women of childbearing age (15-49 years old) have a negative serum or urine HCG test within 7 days before treatment, and agree to use medically approved measures for contraception during treatment and 120 days after treatment ends
  • Males who have not been sterilized must agree to take effective contraceptive measures during the study period and at least 120 days after the last dose of PD-1 monoclonal antibody
  • Patients can provide enough tissue samples for PD-L1 detection or exploratory research.
  • The patient signs an informed consent and voluntarily participates in the clinical trial

Who cannot join

  • Patients who pathologically confirmed non-squamous cell carcinoma
  • Patients who has recurrence or distant metastasis
  • Local lesions have been surgically removed
  • Patients who have received systemic anti-cancer therapy, including hormone therapy
  • Patients who have received treatment targeting PD-1 or PD-L1
  • Patients with active autoimmune disease or a history of autoimmune disease but may relapse(Patients with the following diseases are not excluded and can be further filtered)
Show all 38Show fewer
  • Controlled type 1 diabetes
  • Hypothyroidism(If it can be controlled with hormone replacement therapy)
  • Controlled celiac disease
  • Skin diseases that do not require systemic treatment such as Vitiligo, Psoriasis and Hair loss.
  • Any other disease that is not expected to recur without external triggers
  • Any active malignant tumors within 2 years before treatment, except for the specific cancers being studied in this trial and locally recurring cancers that have been cured (such as resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical in situ Cancer or breast cancer)
  • Any disease requiring systemic treatment with corticosteroids (referring to treatment with a dose higher than 10 mg/day of prednisone or equivalent doses of similar drugs) or other immunosuppressive treatments within 14 days before treatment.
  • However, patients who have currently or previously used any of the following steroid regimens can be selected:
  • Adrenaline replacement steroids(Prednisone ≤10mg/day or equivalent dose of similar drugs)
  • Local, ophthalmic, intra-articular, intranasal and inhaled corticosteroids which is Systemic absorbed Minimally
  • Prophylactically short-term (≤7 days) use of corticosteroids (for example, allergy to contrast agents) or for the treatment of non-autoimmune conditions (for example, delayed hypersensitivity reactions caused by contact allergens)
  • Uncontrolled diabetes within 14 days before treatment or laboratory abnormalities with potassium, sodium and corrected calcium levels> 1 after standard drug treatment or hypoalbuminemia grade ≥ 3
  • History of the following diseases: interstitial lung disease, non-infectious pneumonia or uncontrollable diseases, including pulmonary fibrosis, acute lung disease, etc.
  • Severe chronic or active infection (including tuberculosis infection, etc.) that required systemic antibiotics, antibacterial or antiviral treatment occurred within 14 days before the first administration of the study drug
  • The patient is known to have been infected with HIV
  • Untreated patients with chronic hepatitis B or HBV carriers with chronic hepatitis B virus (HBV) DNA ≥ 500 IU/mL or active hepatitis C virus carriers (HCV) should be excluded.
  • Patients can be selected who is Inactive hepatitis B surface antigen (HBsAg) carriers, treated and stable hepatitis B patients (HBV DNA <500 IU/mL) and cured hepatitis C patients.
  • Any surgery requiring general anesthesia has been performed within 28 days before treatment
  • Have had allogeneic stem cell transplantation or organ transplantation
  • Have any of the following cardiovascular risk factors:
  • Cardiogenic chest pain within 28 days before treatment(moderate pain that restricts instrumental activities of daily living)
  • Symptomatic pulmonary embolism within 28 days before treatment
  • Acute myocardial infarction within 6 months before treatment
  • Any history of heart failure that has reached Grade III or IV as defined by the New York Heart Association within 6 months before treatment
  • Grade 2 ventricular arrhythmia within 6 months before the first administration of the study drug
  • Have a history of cerebrovascular accident within 6 months before the first administration of the study drug
  • Have a history of severe hypersensitivity to other monoclonal antibodies
  • Patients with treatment toxicity (caused by previous anti-cancer treatments) have not returned to baseline or stabilized, unless it is an AE that is not considered a possible safety risk (such as hair loss, neuropathy, or specific laboratory abnormalities)
  • History of allergic reactions to cisplatin or other platinum-containing compounds
  • Peripheral nerve disease ≥ Grade 2 defined by NCI CTCAE v5.0 standard Have gotten a live vaccine within 4 weeks before treatment(Seasonal flu vaccines are usually inactivated vaccines and are allowed to be used; The vaccine used in the nasal cavity is a live vaccine and is not allowed to be used)
  • Abuse or dependence on alcohol or drugs and Basic medical conditions (including laboratory abnormalities) that are not conducive to the administration of the study drug , affect the interpretation of drug toxicity or AEs, lead to insufficient compliance with the study execution and possible damage
  • The patient participates in another therapeutic clinical study at the same time

Trial locations and contacts

1 site in 1 country.

Yaqian Han contact

18673176667

hanyaqiancs@163.com

China1 site, 1 recruiting

  • Hunan cancer Hospital

    Changsha, Hunan

    Yaqian Han, 18673176667, hanyaqiancs@163.com

    Recruiting

Other trials in China

About this study

Official title: A Multi-center, Single-arm, Phase II Clinical Study of Camrelizumab in Combination With Albumin Paclitaxel and Cisplatin for Neoadjuvant Treatment of Operable Locally Advanced Head and Neck Squamous Cell Carcinoma

In this single-arm study, pathologically confirmed advanced head and neck squamous cell carcinoma will be enrolled to investigate the efficacy and safety of Camrelizumab in combination With albumin paclitaxel and cisplatin.

Read the detailed description

First, the patient received neoadjuvant therapy once every three weeks for a total of three cycles（Camrelizumab in combination With albumin paclitaxel and cisplatin）.After the neoadjuvant treatment, the patient undergoes surgery and postoperative radiotherapy.According to the surgical margin and postoperative pathological conditions, combined with cisplatin concurrent chemotherapy as appropriate.

Being tested
PD-1 inhibitor, Albumin Paclitaxel, Cisplatin
Keywords
immunotherapy, PD-1 checkpoint inhibitor, neoadjuvant chemotherapy
Medical subject headings
Head and Neck Neoplasms, Carcinoma, Squamous Cell

What participants receive

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

  • PD-1 inhibitorDrug

    Intravenous administration of SHR1210 (200mg/3weeks)

  • Albumin PaclitaxelDrug

    Albumin Paclitaxel(260mg/m²),every 3 weeks

  • CisplatinDrug

    Cisplatin（80mg/m²）, every 3 weeks

Study groups in NCT04922450
Study groupRoleWhat they receive
Camrelizumab，albumin paclitaxel and cisplatin.ExperimentalParticipants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy. The duration of treatment will till death, or unacceptable toxicity show up.
Receives: Drug: PD-1 inhibitor; Drug: Albumin Paclitaxel; Drug: Cisplatin

What is being measured

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

  1. Clinical remission rate(CRR)

    the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

    Measured: immediately after the surgery

  2. Pathological remission rate(PRR)

    the short-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

    Measured: immediately after the surgery

Secondary outcomes (2)

  1. 2-year survival rate, 2-year progression-free survival rate, 2-year recurrence-free survival rate, 2-year survival rate without distant metastasis

    1. the long-term efficacy of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

    Measured: 2 year

  2. Adverse event rate

    The safety of Camrelizumab combined with albumin paclitaxel/cisplatin neoadjuvant treatment of operable locally advanced head and neck cancer

    Measured: 2 year

Timeline

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

  1. First posted10 Jun 2021
  2. Study start20 Jan 2021
  3. Primary completion20 Jan 2023 (estimated)
  4. Study completion20 Jan 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
Model description
Patients fulfilling Eligibility Criteria will be included in our study.Participants will be given intravenous administration of Camrelizumab (200mg)，Albumin Paclitaxel(260mg/m²) and Cisplatin（80mg/m²）,After completing three times every three weeks of neoadjuvant therapy, The Participants will undergo surgery and Postoperative intensity modulated chemotherapy.Treatments will be administrated until death, or unacceptable toxicity.
Masking
None (open label)
Enrolment
53 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04922450
Sponsor's protocol ID
HNIC21
Status last verified
May 2021
First submitted
24 May 2021
Last updated
10 Jun 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 inhibitor, Albumin Paclitaxel and Cisplatin in people with Head and Neck Cancer and Squamous Cell Carcinoma, run by Hunan Cancer 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 11 inclusion and 38 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 10 Jun 2021. 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 Yaqian Han (18673176667, hanyaqiancs@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical remission rate(CRR) (time frame: immediately after the surgery). The study lists 2 primary outcomes in all. 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 NCT04922450.

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 10 Jun 2021.

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