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Official title Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma
ClinicalTrials.gov ID: NCT05290194
What this study is testing
What is PD-1 inhibitor?
PD-1 inhibitor is an investigational medicine, being studied as a potential treatment for radiotherapy.
Also referred to as Immune Checkpoint Inhibitors.
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 is a single-arm, multicenter, prospective, open-label phase II clinical trial of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy treating oligometastatic nasopharyngeal carcinoma, the main purpose of which is to evaluate the efficacy of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal 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 to 70
You may be able to join if
- The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;
- The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin...
- Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;
- ECOG PS score 0-2 points;
- Aged 18-70 years old;
You likely can't join if
- Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;
- Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined...
- Central nervous system metastastic (confirmed or suspected);
- Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors...
- Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering...
- Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications...
See the full eligibility criteria
Who can join
- The patient was histologically or cytologically diagnosed with nasopharyngeal carcinoma;
- The patient was newly diagnosed with metastatic nasopharyngeal carcinoma (AJCC eighth edition), and after 4-6 cycles of gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen, the how well it works...
- Except for the primary tumor and cervical lymph node metastasis, less than 5 distant organ metastases, and were suitable for SBRT radiotherapy;
- ECOG PS score 0-2 points;
- Aged 18-70 years old;
- Major organ function met the following criteria (14 do not allow the use of any blood components and cell growth factor):
- Neutrophil ANC ≥ 2.0 × 10\^9/L; platelet count PLT ≥ 100 × 10\^9/L; hemoglobin HB ≥ 90 g/L;
- Serum albumin ≥ 28 g/L;
- Alanine aminotransferase ALT, aspartate aminotransferase AST ≤ 2.5 × ULN; if there is liver metastasis, ALT and AST ≤ 5 × ULN;
- Serum creatinine ≤ 1.5 × ULN, Or creatinine clearance ≥ 60 mL/min;
- INR ≤ 1.5 × ULN, and APTT ≤ 1.5 × ULN;
- Life expectancy ≥ 12 weeks;
- The subject who voluntarily joins the study, sign informed consent, and coordinates with follow-up.
What rules you out
- Recurrent and metastatic nasopharyngeal carcinoma after initial treatment;
- Patients received previous treatment of primary lesion or metastasis except for the standard first-line regimen (gemcitabine plus cisplatin combined with PD-1 monoclonal antibody regimen), including induction...
- Central nervous system metastastic (confirmed or suspected);
- Allergy to PD-1 monoclonal antibody or other PD-1 monoantibody; intolerance or allergy to capecitabine; suffering any disease or extrinsic factors affecting oral drugs;
- Uncontrolled cardiac clinical symptoms or diseases, such as: ① heart failure of NYHA Grade II or higher ; ② unstable angina pectoris; ③ suffering myocardial infarction within 1 year; ④ patients with supraventricular or...
- Severe infection (CTCAE 5.0 ≥ 2) 4 weeks before the first use of study drugs, such as severe pneumonia, bacteremia, infectious complications requiring hospitalization; baseline chest imaging examination suggests the...
- History of other malignancies within 5 years or at the time,but except for cured cutaneous basal cell carcinoma and cervical carcinoma in situ, breast carcinoma in situ, superficial bladder tumors (Ta, Tis and T1) and...
- Any of the following conditions is met:
- Received any investigational drug before the first use of the study drug;
- Participated in another clinical study at the same time, unless it is an observational (non-treatment) clinical study or treatment clinical study at the follow-up time;
- Required systemic treatments with corticosteroids (the dose higher than the equivalent dose of 10 mg prednisone per day) or other immunosuppressive agents 2 weeks before the first use of the study drug, except for local...
- Received anti-tumor vaccines or vaccinated live vaccines 4 weeks before the first dose of study drug;
- Underwent excessive surgery or severe trauma 4 weeks before the first use of study drug;
- Patients had active autoimmune diseases and a history of autoimmune diseases (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not...
- History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;
- Patients with active pulmonary tuberculosis infection found by medical history or CT examination, or with a history of active pulmonary tuberculosis infection within 1 year before enrollment, or with a history of active...
- Patients with active hepatitis (HBV ≥ 2000 IU/ml or HBV DNA ≥ 10000/ml), or hepatitis C (hepatitis C antibody positive, and HCV-RNA ≥ 1000/ml);
- Patients with coagulation abnormalities (PT \> 16s, APTT \> 43s, TT \> 21s, Fbg \ 30ml within 3 months), hemoptysis (bleeding \> 5ml within 4 weeks) within 12 months due to thromboembolic events (including stroke events...
- Uncontrolled hypertension (systolic blood pressure \> 140 mmHg, or diastolic blood pressure \> 90 mmHg); coronary heart disease, arrhythmia ≥ grade II (including QTc prolongation, male \> 450 ms, female \> 470 ms) and...
- Urine protein ≥ + +, or 24 hour urine protein ≥ 1.0 g;
- Current diarrhea-related diseases (e.g., ulcerative colitis, Crohn's disease, chronic diarrhea, etc.);
- Known history of psychotropic drug abuse, alcoholism and drug abuse; or current history of antiepileptic drug use;
- Pregnant or lactating;
- Patients considered unsuitable for inclusion by the investigator as assessed by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Zhuhai, 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 Zhuhai, 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.