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New treatment option for Metastatic Nasopharyngeal Carcinoma
Official title Metastatic Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT06886347
What this study is testing
What is Penplimab Injection?
Penplimab Injection is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic 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
- To evaluaate the efficacy and safety of the regimen incuding Penpulimab, Gemcitabine and Anlotinib in the treatment of metastatic nasopharyngeal carcinoma. Using Progression-Free-Survival as the primary endpoint.
- Phase 1: an early, usually small safety study
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 75
You may be able to join if
- The participants voluntarily signed an informed consent form.
- Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- xpected survival of ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
You likely can't join if
- ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. people with other malignancies that have...
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
- Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory...
- Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent...
- Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
- Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.
See the full eligibility criteria
- The participants voluntarily signed an informed consent form.
- Age of ≥ 18 years and ≤ 75 years at the time of enrollment.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- xpected survival of ≥ 3 months.
- Histologically or cytologically confirmed diagnosis of stage IVb NPC (AJCC 8th).
- Metastatic NPC patients who have not recieved the first-line platinumbased chemotherapy.
- At least one measurable tumor lesion per RECIST 1.1 criteria.
- Adequate organ function.
- Female participants of childbearing potential must agree to use contraception (such as intrauterine device, contraceptive pill, or condom) during the study and for 6 months after the end of the study; must have a...
- The people are willing and able to comply with the visit schedule, treatment plan, laboratory examination, and other requirements of the study.
- ubjects have had another malignancy within 3 years before the first dose, except nasopharyngeal carcinoma. people with other malignancies that have been cured by local therapy such as basal or cutaneous squamous cell...
- Participation in treatment with an investigational drug or use of an investigational device within 4 weeks before first study dosing.
- Palliative local treatment was performed for non target lesions within 2 weeks before the first administration; Received nonspecific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc., excluding...
- Progression during or within 6 months after receiving systemic treatment for locally advanced disease (including induction therapy, concurrent radiotherapy, adjuvant therapy) (excluding oral single agent chemotherapy...
- Patients with local recurrence and distant metastasis after radical treatment for locally advanced disease.
- Patients with recurrent nasopharyngeal lesions after radiotherapy and who have received secondary radiotherapy.
- Have previously received immunotherapy, including immune checkpoint inhibitors, immune checkpoint agonists , immune cell therapy, and other treatments against tumor immune mechanism.
- Previously received anti angiogenic therapy.
- According to the judgment of the investigator, there are people with concomitant diseases that seriously endanger the safety of people or affect the completion of the study, or people who believe that there are other...
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, 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.