Trial Title:
Targeted or Chemotherapy Combined With Immunotherapy Versus Chemotherapy for PD-1 Inhibitor Refractory R/M NPC
NCT ID:
NCT05549466
Condition:
Nasopharyngeal Carcinoma
Conditions: Official terms:
Nasopharyngeal Carcinoma
Gemcitabine
Capecitabine
Docetaxel
Apatinib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Apatinib, Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Description:
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.
Arm group label:
Apatinib plus Camrelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Apatinib, Camrelizumab
Description:
Apatinib, po, 250mg, qd. Camrelizumab, iv, 200mg, D1, Q3W.
Arm group label:
Apatinib plus Camrelizumab
Intervention type:
Drug
Intervention name:
Camrelizumab, Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Description:
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.
Arm group label:
Camrelizumab and Chemotherapy
Intervention type:
Drug
Intervention name:
Chemotherapy (gemcitabine/ capecitabine/ docetaxel)
Description:
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.
Arm group label:
Chemotherapy
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Male or female; 18-70 years of age;
2. Had histopathologically confirmed nonkeratinizing recurrent/metastatic NPC (AJCC,
8th; the metastatic tissue biopsy is preferred, not necessary).
3. ECOG performance status of 0 or 1.
4. Progression after previous treatment with platinum-based dual-drug chemotherapy.
5. Progression after previous treatment with PD-1 inhibitors.
6. Experieced at least 1 line systemic therapy.
7. Subjects enrolled must have measurable lesion(s) according to response evaluation
criteria in solid (RECIST) v1.1.
8. Adequate organ function assessed by laboratory parameters during the screening
period
9. Life expectancy more than 12 weeks.
10. Able to understand and sign an informed consent form (ICF).
Exclusion Criteria:
1. Recurrent lesions suitable for radical treatment (radiotherapy or surgery).
2. Previous treatment over 2 lines.
3. 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.
4. Prior use of any anti-VEGF(R) agents.
5. Patients with other malignancies.
6. 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.
7. 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).
8. 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.
9. Patients with known or suspected autoimmune diseases including dementia and
seizures.
10. Multiple factors affecting the absorption of oral medications (e.g., dysphagia,
chronic diarrhea, and bowel obstruction).
11. An excessive dose of glucocorticoids given within 4 weeks before enrollment.
12. Complications requiring long-term use of immunosuppressive drugs or systemic or
local use of immunosuppressive-dose corticosteroids.
13. Patients with active pulmonary tuberculosis (TB) receiving anti-TB treatment or who
have received anti-TB treatment within 1 year prior to screening.
14. 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).
15. Any anti-infective vaccines such as influenza vaccine, varicella vaccine, etc.,
within 4 weeks before enrollment.
16. Women of childbearing age with a positive pregnancy test and lactating women.
17. Special attention: Patients with active bleeding, ulcers, and bowel perforations
within 30 days after major surgery with tumors in close proximity to the internal
carotid artery or other major vessels, and those at risk of major bleeding are
prohibited.
18. Patients considered unsuitable for inclusion.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Nasopharyngeal Carcinoma, Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Ming-Yuan Chen, MD,PhD
Phone:
86-20-8734-2422
Email:
chmingy@mail.sysu.edu.cn
Start date:
October 8, 2022
Completion date:
September 20, 2025
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05549466
