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New treatment option for Nasopharyngeal Cancinoma (NPC)
Official title LDRT Combined With Toripalimab and Chemotherapy for Recurrent/Metastatic NPC
ClinicalTrials.gov ID: NCT07325539
What this study is testing
What is Gemcitabine(GEM)?
Gemcitabine(GEM) is an investigational medicine, being studied as a potential treatment for nasopharyngeal cancinoma (npc).
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 aims to evaluate the efficacy and safety of LDRT combined with toripalimab and GP chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma through a prospective, open-label, single-arm Phase II clinical trial.
- 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 65
You may be able to join if
- Age: 18-65 years old.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).
- ECOG Performance Status score of 0-1.
- At least one measurable lesion as per RECIST v1.1 criteria.
- Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12...
You likely can't join if
- Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.
- Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.
- Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.
- Requirement for systemic use of corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to...
- Recurrent target lesions suitable for curative surgery or a second course of radiotherapy.
- History of any active autoimmune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell...
See the full eligibility criteria
- Age: 18-65 years old.
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO Type II or III).
- ECOG Performance Status score of 0-1.
- At least one measurable lesion as per RECIST v1.1 criteria.
- Patients with newly diagnosed metastatic NPC, or patients with locoregionally advanced NPC who developed metastasis ≥6 months or recurrence ≥12 months after completing radical radiotherapy/chemotherapy for the primary...
- No prior radiotherapy, chemotherapy, immunotherapy, or biological therapy for recurrent/metastatic lesions.
- Adequate organ function, meeting the following criteria within 7 days prior to treatment:
- Hematological criteria (without transfusion or hematopoietic growth factor support within 14 days):
- Hemoglobin (Hb) ≥90 g/L.
- White Blood Cell (WBC) count ≥4.0 × 10⁹/L.
- Platelet count (PLT) ≥100 × 10⁹/L.
- Biochemical criteria:
- Total Bilirubin (TBIL) ≤1.5 × Upper Limit of Normal (ULN).
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤2.5 × ULN.
- Serum Creatinine (Cr) ≤1.5 × ULN AND Creatinine Clearance (CCr) ≥60 mL/min.
- Coagulation function: INR and APTT ≤1.5 × ULN.
- Normal results for myocardial injury markers, heart failure markers, and electrocardiogram (ECG). For patients with abnormal results in any of these, the investigator will assess the need for Doppler echocardiography.
- Thyroid function: TSH ≤ ULN. If abnormal, FT3 and FT4 levels should be considered; patients can be enrolled if FT3 and FT4 levels are normal.
- Women of childbearing potential must have used reliable contraception, have a negative serum pregnancy test within 7 days before enrollment, and be willing to use adequate contraception during the trial and for 8 weeks...
- Voluntary provision of signed informed consent, with good compliance.
- Disease progression within 6 months after completing standard treatment for locoregionally advanced nasopharyngeal carcinoma.
- Absence of identifiable tumor lesions in both the primary site and locoregional lymph nodes, precluding the development of an LDRT plan.
- Inability to undergo MRI due to reasons such as implanted metal devices or claustrophobia.
- Requirement for systemic use of corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to the first dose or during the study. Inhaled or topical steroids and...
- Recurrent target lesions suitable for curative surgery or a second course of radiotherapy.
- History of any active autoimmune or autoimmune disease, or known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. Exceptions include type I diabetes, hypothyroidism...
- Active or uncontrolled severe infection (≥CTCAE Grade 3) within 4 weeks prior to enrollment.
- History of active tuberculosis within the past year, regardless of treatment. Patients with a history of active pulmonary tuberculosis over 1 year ago who have documented evidence of adequate past anti-tuberculosis...
- History of hypertension that cannot be adequately controlled with a single antihypertensive medication (systolic BP ≥150 mmHg or diastolic BP ≥90 mmHg).
- Clinically significant bleeding symptoms or definite bleeding tendency, specifically excluding cases of local recurrence with high bleeding risk or cases within 1 year post-radiotherapy assessed to have a high risk of...
- Urinalysis showing urine protein ≥ ++ AND confirmed 24-hour urine protein ≥1.0 g.
- Myocardial ischemia (above Grade I), myocardial infarction, arrhythmia (including QTc ≥480 ms), or ≥ Grade 2 congestive heart failure (NYHA classification) within 6 months prior to enrollment.
- If an echocardiogram is required per Inclusion Criterion 7(4), results showing Left Ventricular Ejection Fraction (LVEF) below the lower limit of normal (60%).
- Diagnosis of other malignancies within 5 years prior to enrollment, except for cured non-melanoma skin cancer, carcinoma in situ of the cervix, and papillary thyroid carcinoma.
- Presence of leptomeningeal or central nervous system metastases.
- HIV positive, TP positive, liver cirrhosis, decompensated liver disease, active hepatitis (uncontrolled active hepatitis despite treatment: Hepatitis B - HBsAg positive and HBV DNA ≥1 × 10⁴ copies/mL; Hepatitis C - HCV...
- Participation in another anti-tumor drug clinical trial within 4 weeks prior to enrollment.
- Administration of any live attenuated vaccine within 30 days prior to enrollment.
- Contraindications to radiotherapy.
- Known allergy to the study drug or any of its excipients, or history of severe allergic reactions to other monoclonal antibodies.
- History of psychoactive drug abuse unable to be abstained, or presence of psychiatric disorders.
- Any other condition assessed by the investigator as potentially endangering the patient's safety or compliance, including severe concurrent diseases (including psychiatric disorders) requiring prompt treatment, severely...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Shenzhen, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Shenzhen, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
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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.