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Head and Neck Squamous Cell CancerPhase 2HNSCCNCT03975270

Sintilimab in Combination With Nab-paclitaxel in Patients With HNSCC (Head and Neck Squamous Cell Carcinoma )

A Phase 2 study testing Sintilimab and Nab-paclitaxel in people with Head and Neck Squamous Cell Cancer, run by Shengyu Zhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Clinical studies related to immunotherapy of HNSCC have shown that PD1 monoclonal antibody has better clinical benefits than conventional chemotherapy. This phase II clinical study is a single arm, open, single-center study. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Head and Neck Squamous Cell Cancer
What is being tested?
Sintilimab and Nab-paclitaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteChina
Study dates
20 Jul 2019to 31 May 2021
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

  • Age (> 18 years old) and (< 70 years old) are acceptable for both men and women.
  • Understand the steps and contents of the experiment and sign the written informed consent voluntarily;
  • Histopathology was locally recurrent/metastatic squamous cell carcinoma of the head and neck.
  • In the past, at least one line of platinum-containing chemotherapy or combined with EGFR monoclonal antibody targeting therapy failed or relapsed. Definition of treatment failure: progress after chemotherapy or treatment after ecurrence/metastasis; progress within 6 months after concurrent radiotherapy and chemotherapy can be counted as first-line treatment; all treatment changes due to drug intolerance are not counted as treatment failure;
  • Agree to provide archived specimens of tumor tissue or fresh tissue (not necessarily tissue specimens);
  • ECOG score 0-2;
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  • Expected survival of more than 3 months;
  • Computed tomography scans erformed within 28 days prior to the study should show that there is at least one clearly measurable tumor lesion in two vertical directions, the shortest diameter of which is greater than or equal to 1.0 cm (according to RESIST 1.1 standard).
  • Systematic chemotherapy and targeted therapy have been completed for at least 2 weeks before the study, and extensive/local palliative radiotherapy has been completed for at least 4 weeks.
  • Before the study, corticosteroids (prednisone > 10 mg/day or equivalent dose) were discontinued for at least two weeks.
  • Major operations requiring general anesthesia must have been completed for at least four weeks before drug use is studied; operations requiring local anesthesia/epidural anesthesia must have been completed for at least two weeks and the patient has recovered; skin biopsy requiring local anesthesia has been completed for at least one hour;
  • Previous antineoplastic biotherapies (cancer vaccines, cytokines or growth factors for tumour control) were completed for at least four weeks before the study.
  • Hemoglobin (> 90 g/L), neutrophils (> 1.0 *109/L) and platelets (> 80 *109/L) are required for routine blood tests (no blood transfusion or use of biological stimulating factors within 14 days prior to detection).
  • Serum creatinine (< 1.5 *ULN) or creatinine clearance (>50 mL/min) (Cockcroft-Gault formula);
  • Total bilirubin < 1.5 *ULN (Gilbert syndrome allows < 5 *ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2.5 *ULN (patients with liver metastasis allow AST and/or ALT < 5 *ULN);
  • Thyroid function indicators: thyroid stimulating hormone (TSH), free thyroxine (FT3/FT4) in the normal range; if TSH is not in the normal range, FT3/FT4 in the normal range can be included in the group;
  • Adverse reactions caused by previous treatments recovered to grade 1 or below before admission (except for grade 2 neurotoxicity caused by alopecia and chemotherapeutic drugs).
  • Women who were confirmed not to be pregnant within 7 days prior to the study were required to agree to take medically approved effective contraceptive measures throughout the trial period and within 6 months after the end of the trial. 19. Patients can follow up on schedule, communicate well with researchers and complete the study in accordance with the research requirements.
  • -

Who cannot join

  • Patients who meet any of the following conditions will not be allowed to enter the study:
  • Patients diagnosed as nasopharyngeal or thyroid cancer;
  • To clarify the infiltration of the central nervous system (CNS), including brain parenchyma, meningeal invasion or spinal cord compression.
  • History of organ transplantation or hematopoietic stem cell transplantation in the past;
  • Patients with other malignant tumors (excluding cured cervical carcinoma in situ or basal cell or squamous cell carcinoma) may not participate in the study unless they have complete remission for at least five years prior to admission and need no other treatment or treatment during the study period;
  • History of active and known autoimmune diseases, including, but not limited to, systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel disease, Hashimoto's thyroiditis, with the exception of type I diabetes mellitus, hypothyroidism controlled only by hormone replacement therapy, skin diseases without systemic treatment (such as vitiligo, psoriasis), controlled milk Celiac disease, or disease that is not expected to recur without external stimuli.
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  • Anti-PD-1 antibody, anti-PD-L1 antibody, anti-PD-L2 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell co-stimulation or checkpoint pathway) have been used before.
  • Uncontrolled hypertension (systolic pressure > 140 mmHg and/or diastolic pressure > 90 mmHg) or pulmonary hypertension or unstable angina pectoris; myocardial infarction or bypass or stent surgery within 6 months prior to administration; a history of chronic heart failure at NYHA grade 3-4; clinically significant valvular disease; severe arrhythmias requiring treatment, including QTc interval males For women (> 450 ms, 470 ms), left ventricular ejection fraction (LVEF) < 50%, cerebrovascular accident (CVA) or transient ischemic attack (TIA) within 6 months before administration, etc.
  • Complicated with serious medical diseases, including but not limited to uncontrolled diabetes, active gastrointestinal ulcer, active hemorrhage, etc.
  • Active infections requiring systemic treatment;
  • Past or current patients with active tuberculosis infection;
  • Acquired immunodeficiency syndrome antibody (Anti-HIV) and anti-Treponema pallidum antibody (TP-Ab) were positive; hepatitis C antibody (HCV-Ab) was positive and hepatitis C virus RNA quantification was higher than the upper limit of detection unit normal value; hepatitis B surface antigen (HBV-Ag) was positive and HBV DNA quantification was higher than the upper limit of detection unit normal value;
  • Complications requiring immunosuppressive drugs or systemic treatment at a dose of immunosuppressive drugs (prednisone > 10mg/day or equivalent dose of the same drug) are allowed to inhale or locally use steroids or doses of prednisone > 10mg/day or equivalent doses of the same drug in the absence of active autoimmune diseases.
  • Other research drugs were used within 30 days prior to the start of the study or within 5 half-lives (whichever is short) of other research drugs; or research instruments were used within 30 days prior to the start of the study.
  • To study the use of live or attenuated vaccines within four weeks before medication.
  • Uncontrolled or markedly symptomatic serous effusion such as pleural, abdominal, pelvic and pericardial effusion;
  • Those who have a history of drug abuse or drug abuse upon inquiry;
  • History of interstitial lung disease;
  • Lactating women are unwilling to stop breastfeeding.
  • Allergies to recombinant humanized monoclonal antibodies or any of their excipients are known; a history of severe allergic diseases is known;
  • Patients do not communicate, understand and cooperate enough, or have poor compliance, which can not guarantee that they can carry out according to the requirements of the program.
  • Researchers believe that for various other reasons, it is not appropriate for participants in this clinical trial to withdraw from the study or terminate the treatment.

Trial locations and contacts

1 site in 1 country.

Shengyu ZHOU, doctor contact

13520852899

typhoonwho@126.com

China1 site

  • Department of Medical Oncology, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs

    Beijing, 100021

Other trials in China

About this study

Official title: An Exploratory Study of Sintilimab in Combination With Nab-paclitaxel in Patients With Advanced Recurrent or Metastatic HNSCC (Head and Neck Squamous Cell Carcinoma )After 2 or More Prior Lines of Therapy

Clinical studies related to immunotherapy of HNSCC have shown that PD1 monoclonal antibody has better clinical benefits than conventional chemotherapy. This phase II clinical study is a single arm, open, single-center study. The aim of this study is to observe and evaluate the efficacy and safety of Sintilimab combined with paclitaxel-albumin-binding for injection in patients with advanced recurrent and metastatic HNSCC who fail to receive first-line or more treatment. Participation in this study for treatment may benefit patients with advanced recurrence or metastasis of HNSCC.

Being tested
Sintilimab and Nab-paclitaxel

What participants receive

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

  • Sintilimab and Nab-paclitaxelDrug

    Also called IBI308

    Sintilimab in Combination with Nab-paclitaxel in Patients with Advanced Recurrent or Metastatic HNSCC after 2 or More Prior Lines of Therapy

Study groups in NCT03975270
Study groupRoleWhat they receive
Sintilimab in Combination With Nab-paclitaxeExperimentalSintilimab 200 mg intravenous drip, first day Nab-paclitaxe120 mg/m2, intravenous drip, first day and eighth day
Receives: Drug: Sintilimab and Nab-paclitaxel

What is being measured

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

  1. ORR

    Objective mitigation rate assessed by RECIST 1.1 standard

    Measured: 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 Jun 2019
  2. Study start20 Jul 2019 (estimated)
  3. Primary completion31 May 2021 (estimated)
  4. Study completion31 May 2021 (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
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03975270
Sponsor's protocol ID
HNSCC-2LIOS-001
Acronym
HNSCC
Status last verified
Jun 2019
First submitted
21 May 2019
Last updated
18 Jul 2019
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 Sintilimab and Nab-paclitaxel in people with Head and Neck Squamous Cell Cancer, run by Shengyu Zhou 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 19 inclusion and 22 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 18 Jul 2019. 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 Shengyu ZHOU, doctor (13520852899, typhoonwho@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 2 years). 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 NCT03975270.

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 18 Jul 2019.

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