Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC
Antiangiogenic Therapy or Chemotherapy Combined With PD-1 Inhibitor Versus Standard Chemotherapy for PD-1 Inhibitor Refractory R/M NPC
1 other identifier
interventional
84
1 country
1
Brief Summary
Because most patients with R/M NPC have received long-term maintenance of immunotherapy at the time of initial treatment and the first-line treatment, there are a large number of PD-1 inhibitor refractory patients. How to deal with the ICIs resistance is an urgent problem in clinical practice. Based on previous clinical trials, anti-angiogenic drugs combined with immunotherapy were found to be effective. Therefore, this study intends to preliminarily evaluate which treatment regimen can provide the most benefit to PD-1 inhibitor refractory patients by comparing the efficacy of VEGFR inhibitor or standard chemotherapy combined with PD-1 inhibitor.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Oct 2022
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2022
CompletedFirst Posted
Study publicly available on registry
September 22, 2022
CompletedStudy Start
First participant enrolled
October 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 20, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 20, 2025
CompletedFebruary 8, 2023
February 1, 2023
12 months
September 17, 2022
February 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Objective response rate (ORR)
Objective response rate is the rate of patients achieving complete response or partial response for a certain period of time after intervention.
1 year
Secondary Outcomes (5)
Median progression-free survival (PFS)
3 years
Median overall survival (OS)
3 years
Duration of response (DoR)
3 years
Disease control rate (DCR)
1 year
Adverse events
3 years
Study Arms (4)
Apatinib plus Camrelizumab and Chemotherapy
EXPERIMENTALApatinib plus Camrelizumab
EXPERIMENTALCamrelizumab and Chemotherapy
EXPERIMENTALChemotherapy
ACTIVE COMPARATORInterventions
Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W. Camrelizumab, iv, 200mg, D1, Q3W.
Gemcitabine, iv, 1000 mg/m\^2, D1+D8, Q3W, 6 cycles; or capecitabine, po, 1250 mg/\^2, D1-14, BID, Q3W; or docetaxel, iv, 75 mg/m\^2, D1, Q3W.
Eligibility Criteria
You may qualify if:
- Male or female; 18-70 years of age;
- Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC, 8th; the metastatic tissue biopsy is preferred, not necessary).
- ECOG performance status of 0 or 1.
- Progression after previous treatment with platinum-based dual-drug chemotherapy.
- Progression after previous treatment with PD-1 inhibitors.
- Experieced at least 1 line systemic therapy.
- Subjects enrolled must have measurable lesion(s) according to response evaluation criteria in solid (RECIST) v1.1.
- Adequate organ function assessed by laboratory parameters during the screening period
- Life expectancy more than 12 weeks.
- Able to understand and sign an informed consent form (ICF).
You may not qualify if:
- Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
- Previous treatment over 2 lines.
- Patients who had previously received one of the three chemotherapy drugs and were randomly assigned to single-agent chemotherapy (control group) were not eligible to reuse the same treatment in this study. In addition, patients who had previously received all three chemotherapy agents for R/M lesions were excluded from the study.
- Prior use of any anti-VEGF(R) agents.
- Patients with other malignancies.
- Patients with nasopharyngeal necrosis found by endoscope before enrollment or with a \> 50% chance of nasopharyngeal necrosis according to the risk prediction model: ① Patients with recurrent stage T3-4 received two courses of radiotherapy before enrollment, or received nasopharyngeal radiotherapy within 1 year before enrollment; ② Patients with recurrent T1-2 stage had received two courses of radiotherapy and nasopharyngeal radiotherapy within 1 year before enrollment.
- Patients with or previous with serious hemorrhage (bleeding \>30 ml within 3 months), haemoptysis (\> 5 ml within 4 weeks) of thromboembolic events within 12 months (including stroke events and/or transient ischemic attack).
- Patients with hypertension who cannot be reduced to the normal range by antihypertensive drug treatment (systolic blood pressure \> 140 mmHg/diastolic blood pressure \> 90 mmHg), patients with ≥ grade II coronary heart disease, arrhythmia (including QTc interval prolongation \> 450 ms in men and \> 470 ms in women) and cardiac insufficiency.
- Patients with known or suspected autoimmune diseases including dementia and seizures.
- Multiple factors affecting the absorption of oral medications (e.g., dysphagia, chronic diarrhea, and bowel obstruction).
- An excessive dose of glucocorticoids given within 4 weeks before enrollment.
- Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
- Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who have received anti-TB treatment within 1 year prior to screening.
- HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
- Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc., within 4 weeks before enrollment.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ming-yuan Chen, MD, PhD
Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief physician, Professor
Study Record Dates
First Submitted
September 17, 2022
First Posted
September 22, 2022
Study Start
October 8, 2022
Primary Completion
September 20, 2023
Study Completion
September 20, 2025
Last Updated
February 8, 2023
Record last verified: 2023-02