Overview

Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy for Nasopharyngeal Carcinoma

Status:
Not yet recruiting
Trial end date:
2026-06-01
Target enrollment:
0
Participant gender:
All
Summary
This study is to investigate the efficacy and safety of the induction chemotherapy + concurrent chemoradiotherapy(CCRT)combined with toripalimab and endostar treatment, in comparison with the induction chemotherapy + concurrent chemoradiotherapy(CCRT), in treating locally advanced high-risk nasopharyngeal carcinoma
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
First Affiliated Hospital of Guangxi Medical University
Collaborators:
Affiliated Hospital of North Sichuan Medical College
Fourth Affiliated Hospital of Guangxi Medical University
Guilin Medical College
Jiangxi Provincial Cancer Hospital
LiuZhou People's Hospital
Shandong Cancer Hospital and Institute
The Affiliated Hospital Of Guizhou Medical University
Wuhan Union Hospital, China
Xiangya Hospital of Central South University
Zhejiang Cancer Hospital
Treatments:
Endostar protein
Criteria
Inclusion Criteria:

1. With ECOG score 0-1.

2. Subjective aged 18-65 years, male or non-pregnant female.

3. Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated
or undifferentiated, i.e., the WHO type II or III).

4. Stage IVa (8th AJCC/UICC stage) T4 and/or N3, untreated patients with nasopharyngeal
carcinoma.

5. Agreeing to provide previously stored tumor tissue samples or perform biopsy to
collect tumor tissues, which were sent to the central laboratory for the PD-L1 IHC
test.

6. Hematology: white blood cells ≥ 4000 /μL; neutrophils ≥ 2000 /μL; hemoglobin ≥ 9 g/dL;
and platelets ≥ 100000 /μL.

7. Liver function: ALT and AST lower than the 1.5 times (1.5 × ) the upper limits of
normal (ULN); and total bilirubin < 1.5 × ULN.

8. Renal function: serum creatinine < 1.5 × ULN.

9. Patients signing the informed consents, and willing and able to follow the study plan
(visit and treatment plan), laboratory tests, and other research procedures.

Exclusion criteria:

1. Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.

2. Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification
type I).

3. Patients who had undergone radiotherapy or systemic chemotherapy.

4. Pregnant or breastfeeding females, or females in fertility period while with no
effective contraceptive measures.

5. Positive for HIV.

6. Having suffered from other malignant tumors (except for the cured basal cell carcinoma
or cervical carcinoma in situ).

7. Having been treated with inhibitors of immune regulatory points (i.e., CTLA-4, PD-1,
PD-L1, etc.).

8. With complications needing long-term application of immunosuppressive drugs, or
systemic or local application of corticosteroids with immunosuppressive doses of
comorbidities.

9. Patients with immunodeficiency diseases, or a history of organ transplantation
(including but not limited to: interstitial pneumonia, uveitis, enteritis, hepatitis,
pituitary inflammation, nephritis, hyperthyroidism, hypothyroidism; patients suffering
from vitiligo, or asthma in childhood completely relieved, with no need of any
intervention after adulthood could be included; and patients with asthma requiring
bronchodilators for medical intervention could not be included).

10. With excessive usage of glucocorticoids within 4 weeks.

11. Whose laboratory examination values that did not meet the relevant standards within 7
days before participating in the research.

12. Patients with markedly reduced heart, liver, lung, kidney and/or bone marrow
functions.

13. With serious and uncontrolled medical diseases and infections.

14. Using other test drugs or in other clinical trials.

15. Refusing or failing to sign the informed consent to participate in the trial.

16. With other treatment contraindications.

17. With personality or mental illness, with no or limited civil capacity.

18. Positive for hepatitis B surface antigen (HBsAg), and peripheral blood hepatitis B
virus deoxyribonucleic acid (HBV DNA) ≥ 1000 cps/mL.

19. Patients positive for the HCV antibody test could only be included in this study with
the negative results from the HCV RNA polymerase chain reaction test.

20. Unable to cooperate with regular follow-up due to psychological, social, family and
geographical reasons.