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New treatment option for Head and Neck Squamous Cell Carcinoma
Official title Study of Pembrolizumab Combined with Chemotherapy in the First Line Therapy for R/M HNSCC in China
ClinicalTrials.gov ID: NCT04857164
What this study is testing
What is Pembrolizumab combined with Chemotherapy?
Pembrolizumab combined with Chemotherapy is an investigational medicine, being studied as a potential treatment for head and neck squamous cell carcinoma.
Also referred to as keytruda and Chemotherapy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is main evaluate the efficacy and safety of pembrolizumab combined with chemotherapy in the first-line treatment of Chinese patients with recurrent or metastatic head and neck squamous cell carcinoma
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Voluntarily sign written informed consent before screening;
- Age 18\~75 years old;
- ECOG physical status score 0-1 points;
- Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
- Recurrent and/or metastatic HNSCC without indications for local radical treatment;
You likely can't join if
- Patients who are suitable for local treatment and are willing to local treatment;
- Have received systemic chemotherapy, but does not include treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the...
- Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug...
- Other malignant tumors have occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non-...
- Received cetuximab treatment within 6 months before the first administration;
See the full eligibility criteria
Who can join
- Voluntarily sign written informed consent before screening;
- Age 18\~75 years old;
- ECOG physical status score 0-1 points;
- Head squamous cell carcinoma (HNSCC) diagnosed by histology or cytology, the primary site is oral cavity, oral cavity Throat, lower throat or throat;
- Recurrent and/or metastatic HNSCC without indications for local radical treatment;
- According to the evaluation criteria for the how well it works of solid tumors (RECIST version 1.1), there is at least one measurable lesion, right For lesions that have received radiotherapy in the past, only if there...
- There are a large number of tumor tissue samples for PD-L1 immunohistochemical detection;
- The expected survival period exceeds 3 months;
- The main organs function normally, that is, they meet the following standards: I. Blood routine (not receiving blood transfusion 14 months before screening examination, erythropoietin (EPO), granulocyte set Fall...
- L, platelets ≥100×109
- L, hemoglobin≥90g/L; ii. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST), ALT and AST ≤ 3 for those without liver metastasis ×ULN, ALT and AST for liver metastases≤5×ULN; total...
- Women should agree to use contraceptive measures (such as intrauterine birth control) during the study period and within 6 months after the study ends. Device [IUD], contraceptive pill or condom); 7 diabetes blood...
What rules you out
- Patients who are suitable for local treatment and are willing to local treatment;
- Have received systemic chemotherapy, but does not include treatment for locally advanced disease as a part of multimodal treatment Chemotherapy (the end of this treatment must be more than 6 months after the first trial...
- Locally advanced head and neck squamous cell carcinoma multimodal treatment is completed within 6 months of disease progression;
- Have received anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137 or anti-CTLA-4 antibodies or targeting effects in the past Any other antibody or drug immunotherapy in T cell co-stimulation or immune checkpoint pathway;
- Other malignant tumors have occurred within 5 years or at the same time during the current period, except for cured cervical carcinoma in situ, non- Skin cancer of melanoma or other tumors/cancers that have undergone...
- Received cetuximab treatment within 6 months before the first administration;
- According to the standard of common adverse event term (NCI CTCAEv5.0), peripheral neuropathy has been ≥2 grade;
- With known active central nervous system metastasis (CNS) and/or cancerous meningitis: previous treatment people with brain metastases treated for treatment can participate in the study, provided that they are...
- Did not recover from any acute effects of previous surgery, chemotherapy or radiotherapy, that is, did not fall to ≤1 grade (NCI CTCAEv5.0) people (except for hair loss). If the nutritional status is stable, allow...
- Any component of the studied drug or preparation has caused severe allergic reactions, including known Severe allergic reaction to Longan antibody (NCI CTCAEv5.0≥3);
- Have received anti-tumor drug treatment (such as chemotherapy, hormone therapy, immune Disease treatment, antibody treatment, radiotherapy, etc.), except for palliative radiotherapy for bones to relieve pain;
- Chinese herbal medicine or Chinese patent medicine receiving anti-tumor treatment ≤1 week before the first administration;
- Have received major surgery within 4 weeks before the first administration or are expected to undergo major surgery during the study period;
- Immunosuppressive drugs need to be used 2 weeks before the first administration or within 2 weeks or during the study period. The following conditions are excluded:
- Intranasal, inhaled, topical steroid or topical steroid injection (such as intra-articular injection);
- Physiological dose of systemic corticosteroids (≤10mg/day prednisone or equivalent dose);
- Short-term (≤7 days) use of steroids to prevent or treat non-autoimmune allergic diseases;
- people who are known to have active or have a history of autoimmune diseases that are likely to relapse (such as: Systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, autoimmune thyroid...
- people with known history of interstitial lung disease, history of non-infectious pneumonia, or high suspicion of interstitial lung disease Those who have previously had drug-induced or radiation non-infectious...
- A history of human immunodeficiency virus infection (positive HIV test), or other acquired or congenital Immunodeficiency disease, or history of organ transplantation, or history of stem cell transplantation;
- The hepatitis B or C virological examination at the time of screening meets any of the following:
- HBsAg positive, and peripheral blood hepatitis B virus deoxyribonucleic acid (HBV DNA) titer ≥104 Copy number/ml or ≥2000 IU/ml;
- HCV antibody is positive, and HCV-RNA is higher than the detection limit of the analysis method;
- Within 2 weeks or 2 weeks before the first administration, the subject has an active infection that requires systemic treatment or is uncontrollable Infection (except for simple urinary tract infection or upper...
- Live virus vaccine was vaccinated within 4 weeks before the first dose. Allows vaccination against seasonal influenza that does not contain live viruses seedling;
- Serous effusions (such as pleural effusions and pleural effusions) with clinical symptoms that require clinical intervention or stable time less than 4 weeks ascites);
- Known to be accompanied by serious medical diseases, such as heart function abnormalities of grade III and above (New York Heart Association [NYHA]), cardiovascular diseases such as ischemic heart disease (such as...
- Medical or psychiatric history or laboratory abnormal history that may interfere with the interpretation of results;
- The subject is currently enrolled in other research equipment or research drug research, or is away from other research drugs Or the study device is out of use for less than or equal to 4 weeks;
- The subject is known to be addicted to alcohol or drugs;
- The researcher believes that the people have other conditions that may affect their compliance with the protocol and the evaluation of research indicators. Circumstances, people who are not suitable to participate in...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.