NCT04447326

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
106

participants targeted

Target at P50-P75 for phase_2

Timeline
1mo left

Started Jun 2020

Longer than P75 for phase_2

Status
not yet recruiting

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

Study Progress99%
Jun 2020Jun 2026

Study Start

First participant enrolled

June 1, 2020

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

June 23, 2020

Last Update Submit

June 24, 2020

Conditions

Nasopharyngeal Carcinoma

Outcome Measures

Primary Outcomes (1)

  • progression-free survival, PFS

    calculated from the date of randomisation to the date of the documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first. distant failure, or death from any cause, whichever occurred first.

    3 years

Secondary Outcomes (5)

  • Overall Survival，OS

    3 years

  • locoregional relapse-free Survival, LRFS

    3 years

  • Distant metastasis-free survival,DMFS

    3 years

  • Overall response rate (ORR)

    3 months

  • adverse events (AEs) and severe adverse events (SAE)

    3 years

Study Arms (2)

IC＋CCRT＋Toripalimab＋Endostar

EXPERIMENTAL

Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w; Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles; Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles.

Drug: Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy

IC＋CCRT

ACTIVE COMPARATOR

Three cycles of induction chemotherapy with GP regimen (Q3W): Gem 1000 mg/m2 d1,8; DDP 80mg/m2 d1, Q3W; IMRT (6-7 weeks, 5 times each week) combined with cisplatin for 2-3 cycles (Q3W): DDP 100 mg/m2, Q3W, 2-3 cycles; IMRT: GTVnx 70-74Gy/30-33f, 5d/w, 6-7 w.

Drug: IC＋CCRT

Interventions

Toripalimab, Endostar Combined With Radiotherapy and ChemotherapyDRUG

Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles

Also known as: JS001
IC＋CCRT＋Toripalimab＋Endostar
IC＋CCRTDRUG

IC＋CCRT

IC＋CCRT

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • With ECOG score 0-1.
  • Subjective aged 18-65 years, male or non-pregnant female.
  • Pathologically diagnosed as nasopharyngeal non-keratinizing carcinoma (differentiated or undifferentiated, i.e., the WHO type II or III).
  • Stage IVa (8th AJCC/UICC stage) T4 and/or N3, untreated patients with nasopharyngeal carcinoma.
  • 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.
  • Hematology: white blood cells ≥ 4000 /μL; neutrophils ≥ 2000 /μL; hemoglobin ≥ 9 g/dL; and platelets ≥ 100000 /μL.
  • 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.
  • Renal function: serum creatinine \< 1.5 × ULN.
  • Patients signing the informed consents, and willing and able to follow the study plan (visit and treatment plan), laboratory tests, and other research procedures.

You may not qualify if:

  • Patients with nasopharyngeal carcinoma with recurrence and distant metastasis.
  • Pathologically diagnosed as keratinizing squamous cell carcinoma (WHO classification type I).
  • Patients who had undergone radiotherapy or systemic chemotherapy.
  • Pregnant or breastfeeding females, or females in fertility period while with no effective contraceptive measures.
  • Positive for HIV.
  • Having suffered from other malignant tumors (except for the cured basal cell carcinoma or cervical carcinoma in situ).
  • Having been treated with inhibitors of immune regulatory points (i.e., CTLA-4, PD-1, PD-L1, etc.).
  • With complications needing long-term application of immunosuppressive drugs, or systemic or local application of corticosteroids with immunosuppressive doses of comorbidities.
  • 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).
  • With excessive usage of glucocorticoids within 4 weeks.
  • Whose laboratory examination values that did not meet the relevant standards within 7 days before participating in the research.
  • Patients with markedly reduced heart, liver, lung, kidney and/or bone marrow functions.
  • With serious and uncontrolled medical diseases and infections.
  • Using other test drugs or in other clinical trials.
  • Refusing or failing to sign the informed consent to participate in the trial.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • Zhang S, Huang X, Zhou L, Wu G, Lin J, Yang S, Chen J, Lin S. An open-label, single-arm phase II clinical study of induction chemotherapy and sequential Nimotuzumab combined with concurrent chemoradiotherapy in N3M0 stage nasopharyngeal carcinoma. J BUON. 2018 Nov-Dec;23(6):1656-1661.

    PMID: 30610791BACKGROUND

  • Hsu C, Lee SH, Ejadi S, Even C, Cohen RB, Le Tourneau C, Mehnert JM, Algazi A, van Brummelen EMJ, Saraf S, Thanigaimani P, Cheng JD, Hansen AR. Safety and Antitumor Activity of Pembrolizumab in Patients With Programmed Death-Ligand 1-Positive Nasopharyngeal Carcinoma: Results of the KEYNOTE-028 Study. J Clin Oncol. 2017 Dec 20;35(36):4050-4056. doi: 10.1200/JCO.2017.73.3675. Epub 2017 Aug 24.

    PMID: 28837405BACKGROUND

  • Ma BBY, Lim WT, Goh BC, Hui EP, Lo KW, Pettinger A, Foster NR, Riess JW, Agulnik M, Chang AYC, Chopra A, Kish JA, Chung CH, Adkins DR, Cullen KJ, Gitlitz BJ, Lim DW, To KF, Chan KCA, Lo YMD, King AD, Erlichman C, Yin J, Costello BA, Chan ATC. Antitumor Activity of Nivolumab in Recurrent and Metastatic Nasopharyngeal Carcinoma: An International, Multicenter Study of the Mayo Clinic Phase 2 Consortium (NCI-9742). J Clin Oncol. 2018 May 10;36(14):1412-1418. doi: 10.1200/JCO.2017.77.0388. Epub 2018 Mar 27.

    PMID: 29584545BACKGROUND

  • Li Y, Tian Y, Jin F, Wu W, Long J, Ouyang J, Zhou Y. A phase II multicenter randomized controlled trial to compare standard chemoradiation with or without recombinant human endostatin injection (Endostar) therapy for the treatment of locally advanced nasopharyngeal carcinoma: Long-term outcomes update. Curr Probl Cancer. 2020 Feb;44(1):100492. doi: 10.1016/j.currproblcancer.2019.06.007. Epub 2019 Jul 2.

    PMID: 32035692BACKGROUND

  • Kang M, Wang F, Liao X, Zhou P, Wang R. Intensity-modulated radiotherapy combined with endostar has similar efficacy but weaker acute adverse reactions than IMRT combined with chemotherapy in the treatment of locally advanced nasopharyngeal carcinoma. Medicine (Baltimore). 2018 Jun;97(25):e11118. doi: 10.1097/MD.0000000000011118.

    PMID: 29924009BACKGROUND

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

toripalimabRadiotherapyDrug Therapy

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNasopharyngeal NeoplasmsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsHead and Neck NeoplasmsNeoplasms by SiteNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

rensheng wang, Ph.D

CONTACT

86-771-535650913807806008@163.com

min kang, Ph.D

CONTACT

86-771-5356509km1019@163.com

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
professor

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 25, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2024

Study Completion (Estimated)

June 1, 2026

Last Updated

June 25, 2020

Record last verified: 2020-06