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New treatment option for Nasopharyngeal Carcinoma
Official title Gemcitabine + Docetaxel + Toripalimab Induction in Epstein-Barr Virus (EBV) Associated Nasopharyngeal Carcinoma(NPC)
ClinicalTrials.gov ID: NCT06592599
What this study is testing
What is Toripalimab?
Toripalimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for nasopharyngeal carcinoma.
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
- The purpose of the research is to test the safety and efficacy of the investigational drug in human subjects with cancer.
- 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
- Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
- Prior therapy: None for NPC permitted
- Life expectancy: 3 months at least
- Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective...
- ECOG Performance Status of 0,1, or 2
You likely can't join if
- Prior systemic anticancer treatment for NPC
- Prior radiation to head and neck region or regions necessitating overlapping fields
- Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
- History of allergic reactions to any agents in this study
- Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
- Pregnant or breastfeeding
See the full eligibility criteria
- Eligible disease(s) / stage(s): Locoregionally advanced EBV positive NPC (T3-4, any N OR any T, N1-3. No M1) per AJCC v 8
- Prior therapy: None for NPC permitted
- Life expectancy: 3 months at least
- Contraception requirements: Women of childbearing potential and male participants who are sexually active must agree to use a medically effective means of birth control during treatment with toripalimab and for 4 months...
- ECOG Performance Status of 0,1, or 2
- Age: At least 18 years old. CBC/differential obtained within 21 days prior to day 1 of treatment, with adequate bone marrow function defined as follows:
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
- Platelets ≥ 100,000 cells/mm3;
- Hemoglobin ≥ 8.0 g/dl (Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable.); Adequate hepatic function within 21 days prior to day 1 of treatment, defined as follows:
- Total bilirubin ≤ 1.5 x institutional ULN;
- AST and ALT ≤ 1.5 x institutional ULN; Adequate renal function within 21 days prior to day 1 of treatment, defined as follows:
- Serum creatinine ≤ 1.5 mg/dl or calculated or measured creatinine clearance (CC) ≥ 50 ml/min
- Negative serum pregnancy test within 14 days prior to day 1 of treatment for women of childbearing potential
- Ability to understand and the willingness to personally sign the written IRB approved informed consent document.
- Prior systemic anticancer treatment for NPC
- Prior radiation to head and neck region or regions necessitating overlapping fields
- Concurrent use of any anti- cancer treatment, standard, alternative or investigational.
- History of allergic reactions to any agents in this study
- Autoimmune disease or organ transplant which in the judgment of the PI would increase the risk of immune checkpoint inhibition.
- Pregnant or breastfeeding
- Severe, active co-morbidity, defined as follows:
- Major medical or psychiatric illness, which in the investigator's opinion would interfere with the completion of therapy and follow up or with full understanding of the risks and potential complications of the therapy;
- Unstable angina and/or uncontrolled congestive heart failure within past 6 months;
- Myocardial infarction within the last 6 months;
- Current acute bacterial or fungal infection requiring intravenous antibiotics; note that patients receiving IV antibiotics or currently on oral antibiotics whose infection is assessed to be adequately treated or...
- Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days prior to day 1 of treatment;
- Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is...
- Patients with hearing loss assessed to be primarily sensorineural in nature, requiring a hearing aid, or intervention (i.e. interfering in a clinically significant way with activities of daily living); a conductive...
- ≥ grade 2 peripheral sensory neuropathy
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
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 Palo Alto, California, United States. 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.