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New treatment option for Head and Neck Squamous Cell Carcinomas
Official title A Study of Toripalimab as Consolidation Therapy After Postoperative Chemoradiotherapy in HNSCC
ClinicalTrials.gov ID: NCT04992559
What this study is testing
What is Consolidation Toripalimab?
Consolidation Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for head and neck squamous cell carcinomas.
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 study is a phase II, open label, single-arm and exploratory clinical trial. The purpose of this study is to observe the efficacy and safety of consolidation immunotherapy with Toripalimab following postoperative radiotherapy or chemoradiotherapy for patients with locally advanced head and neck squamous cell carcinomas (HNSCC).
- 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 to 70
You may be able to join if
- Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
- Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
- Greater than or equal to 18 and less than 70 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST 1.1.
You likely can't join if
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not...
- Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of...
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the...
- Active, known or suspected autoimmune disease.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
See the full eligibility criteria
- Postoperative with adverse prognostic factors in patients with locally advanced head and neck squamous cell carcinoma.
- Have received postoperative adjuvant radiotherapy (chemo) therapy, and the end of the treatment is not more than 2 months.
- Greater than or equal to 18 and less than 70 years of age at time of study entry.
- ECOG performance status of 0 or 1.
- Measurable disease as per RECIST 1.1.
- Screening labs must meet the following criteria and must be obtained within 14 days prior to registration:
- Adequate hepatic and renal function as demonstrated by
- Serum creatinine \ 40mL/min (if using the Cockcroft-Gault formula below):
- Males: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL)）
- Females: Creatinine CL (mL/min) = (Weight (kg) x (140 - Age))/(72 x serum creatinine (mg/dL))x 0.85
- AST/ALT ≤ 3 x ULN
- Total Bilirubin ≤ 1.5 x ULN (except people with Gilbert Syndrome, who can have total bilirubin \< 3.0 mg/dL)
- Adequate bone marrow function as demonstrated by:
- Absolute Neutrophil Count \>1,500/µL
- Platelets \> 100 X 103/µL
- Hemoglobin \> 9.0 g/dL
- Women of reproductive potential should have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days of study enrollment.
- Women of reproductive potential must use highly effective contraception methods to avoid pregnancy for 3 months after the last dose of study drugs; "women of reproductive potential" is defined as any female who has...
- Men of reproductive potential who are sexually active with women of reproductive potential must use any contraceptive method with a failure rate of less than 1% per year; men who are receiving the study medications will...
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
- Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Is currently participating in or has participated in a study of an investigational agent within 4 weeks of the first dose of treatment or has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to...
- Has had another known invasive malignancy within the previous 5 years （With the exception of basal cell carcinoma of the skin, carcinoma in situ of the cervix, and papillary carcinoma of the thyroid, which has been...
- If subject received major surgery for any other reason, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
- Active, known or suspected autoimmune disease.
- Has evidence of interstitial lung disease or active, non-infectious pneumonitis.
- Has an active infection requiring systemic therapy.
- Has received prior therapy with an anti-PD-1 antibody .
- A history of allergic reaction attributed to compounds of similar chemical or biologic composition to the treatment or other agents used in the study.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 23 weeks after the last dose of trial...
- Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV 1/2 antibodies).
- Has known active Hepatitis B or C.
- Known history of active TB ( bacillus tuberculosis ).
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, 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.