Radiotherapy Combined With PD-1 Monoclonal Antibody and Capecitabine in the Treatment of Nasopharyngeal Carcinoma

NCT05290194 | Recruiting Phase 2

• 1 other identifier: ZDWY[2022]LunziNo.(K11-1)
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiotherapy; PD-1 Inhibitor; Capecitabine; Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progress-free survival

  The time between enrollment and progression(in any way) or death (for any reason)

  2 years

Secondary Outcomes (2)

• Overall survival

  2years

• Duration of response

  2 yaers

Other Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  2 years

Study Arms (1)

Oligometastatic nasopharyngeal carcinoma

EXPERIMENTAL

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.

Radiation: SBRT radiotherapy + Conventionally fractionated radiotherapy; Drug: PD-1 inhibitor; Drug: Capecitabine

Interventions

SBRT radiotherapy + Conventionally fractionated radiotherapy RADIATION

Radiotherapy was performed 3-6 weeks after the end of first-line treatment, followed by conventional fractionated radiotherapy of the primary tumor and cervical lymph node metastases, SBRT radiotherapy of distant organ metastases 3-6 weeks later.

Oligometastatic nasopharyngeal carcinoma

PD-1 inhibitor DRUG

Immunotherapy of PD-1 inhibitor is used during the whole time of this trial until subjects were withdrawn from the trial or the trial complete

Also known as: Immune Checkpoint Inhibitors

Oligometastatic nasopharyngeal carcinoma

Capecitabine DRUG

Capecitabine is treated for patients 3-6 weeks after radiotherapy, which combines with PD-1 inhibitor as the maintenance regimen in the trial.

Also known as: Xeloda

Oligometastatic nasopharyngeal carcinoma

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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;
• 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.

You may not qualify 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 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;
• 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 inflammation and prevention of allergy and nausea and vomiting. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticotropic hormone replacement at doses greater than 10 mg daily in prednisone efficacy dose are allowed;
• 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 limited to these diseases and syndromes) in the past 2 years; patients who did not require any intervention after adulthood are allowed;
• History of immunodeficiency, including HIV positive, or other acquired, congenital immunodeficiency diseases, or history of organ transplantation and bone marrow transplantation;

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Fifth Affilliated Hospital of Sun Yat-sen University

Zhuhai, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

Immune Checkpoint Inhibitors; Capecitabine

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Zhigang MD Liu, PhD

  Fifth Affilliated Hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhigang MD Liu, PhD

CONTACT

2528888; zhigangliu1983@hotmail.com

Zhigang MD Liu, PhD

CONTACT

2528888; liuzhg9@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physicion

Study Record Dates

• First Submitted: March 5, 2022
• First Posted: March 22, 2022
• Study Start: March 28, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

CN (1)