Multi-target Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine Maintenance Therapy Treating Oligometastatic Nasopharyngeal Carcinoma: a Single-arm, Multicenter, Prospective, Open-label Phase II Clinical Trial
Overview
- Phase
- Phase 2
- Intervention
- SBRT radiotherapy + Conventionally fractionated radiotherapy
- Conditions
- Radiotherapy
- Sponsor
- Fifth Affiliated Hospital, Sun Yat-Sen University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Progress-free survival
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Detailed Description
This is a single-arm, multicenter, prospective, open-label phase II clinical study of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy for oligometastatic nasopharyngeal carcinoma. Its primary objective is to assess the efficacy, including progression-free survival (PFS), 2-year overall survival (Two-year OS) and progression-free survival (Two-year PFS), overall survival (OS), duration of response (DOR) and safety of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy in treating oligometastatic nasopharyngeal carcinoma. The secondary objective is to explore the potential genetic biomarkers and clinical therapeutic efficacy evaluation and prediction model of multi-target radiotherapy combined with PD-1 monoclonal antibody and capecitabine maintenance therapy regimen in treating oligometastatic nasopharyngeal carcinoma, providing the evidence of the screening of the potential patients benefiting from the regimen of this trial.
Investigators
Zhigang Liu
Chief physicion
Fifth Affiliated Hospital, Sun Yat-Sen University
Eligibility Criteria
Inclusion Criteria
- •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 efficacy reached more than stable disease;
- •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;
Exclusion Criteria
- •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 chemotherapy, adjuvant chemotherapy, concurrent chemoradiotherapy, surgery and other treatments;
- •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 arrhythmia requiring clinical intervention;
- •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 presence of active pulmonary inflammation; symptoms and signs of infection or the need for oral or intravenous antibiotics (excluding the prophylactic use of antibiotics) 2 weeks before the first use of the study drug;
- •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 papillary thyroid cancer as well as other cancers treated more than 3 years before the start of the study;
- •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-interventional) clinical study or interventional clinical study at the follow-up time;
Arms & Interventions
Oligometastatic nasopharyngeal carcinoma
Patients included are going to receive radiotherapy, chemotherapy and immunotherapy. Radiotherapy includes IMRT and SBRT. IMRT is applied for primary sites and cervical lymph nodes，and SBRT following is applied for oligometastatic sites. PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
Intervention: SBRT radiotherapy + Conventionally fractionated radiotherapy
Oligometastatic nasopharyngeal carcinoma
Patients included are going to receive radiotherapy, chemotherapy and immunotherapy. Radiotherapy includes IMRT and SBRT. IMRT is applied for primary sites and cervical lymph nodes，and SBRT following is applied for oligometastatic sites. PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
Intervention: PD-1 inhibitor
Oligometastatic nasopharyngeal carcinoma
Patients included are going to receive radiotherapy, chemotherapy and immunotherapy. Radiotherapy includes IMRT and SBRT. IMRT is applied for primary sites and cervical lymph nodes，and SBRT following is applied for oligometastatic sites. PD-1 inhibitors: during the whole trial, intravenous, Q3W; Capecitabine: 650mg, po, bid, following the radiotherapy for a year.
Intervention: Capecitabine
Outcomes
Primary Outcomes
Progress-free survival
Time Frame: 2 years
The time between enrollment and progression(in any way) or death (for any reason)
Secondary Outcomes
- Overall survival(2years)
- Duration of response(2 yaers)