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Status unknownNCT03619824Updated Oct 9, 2018

PD-1 Blockade Combined With Definitive Chemoradiation in Locoregionally-advanced Nasopharyngeal Carcinoma

A Phase 2 interventional study of Sintilimab and Gemcitabine in Nasopharyngeal Neoplasms, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-09.

Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This trial plans to enroll 40 patients with stage III-IVA (AJCC 8th, except T3N0-1 or T4N0) locoregionally-advanced nasopharyngeal carcinoma (NPC). Patients will receive 3 cycles of induction chemotherapy with gemcitabine and cisplatin and concurrent cisplatin-radiation. All patients will receive intensity-modulated radiotherapy (IMRT). Sintilimab will begin on day 1 of induction chemotherapy and continue every 3 weeks for 6 cycles.

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Conditions studied

  • Nasopharyngeal Neoplasms
03

In context

Nasopharyngeal Carcinoma

816 studies on the registry are indexed under Nasopharyngeal Carcinoma; 282 are open to participants now.

This study's planned enrollment of 40 is below the median of 84 across 668 interventional studies indexed under Nasopharyngeal Carcinoma.

Browse Nasopharyngeal Carcinoma studies →

Lead sponsor

Sun Yat-sen University is the lead sponsor of 1,644 studies on the registry; 602 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Patients with histologically confirmed nasopharyngeal carcinoma.
  2. Tumor staged as III-IVA (AJCC 8th, except T3N0-1 or T4N0).
  3. ECOG performance status ≤1.
  4. Adequate marrow function: neutrocyte count≥1.5×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
  5. Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 1.5×ULN.
  6. Adequate renal function: creatinine clearance rate ≥ 60 ml/min (Cockcroft-Gault formula).
  7. Patients must be informed of the investigational nature of this study and give written informed consent.
  8. Women of childbearing potential (WOCBP) who are sexually active must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of study drug. Men who are sexually active with WOCBP must be willing to adhere to effective contraception during treatment and for 1 year after the last dose of the study drug.

Exclusion criteria

Exclusion Criteria:

  1. Age > 65 or \< 18.
  2. Hepatitis B surface antigen (HBsAg) positive and HBV DNA >1×10e3 copies/ml
  3. Hepatitis C virus (HCV) antibody positive
  4. Has active autoimmune disease, except type I diabetes, hypothyroidism treated with replacement therapy, and skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia).
  5. Has a known history of interstitial lung disease.
  6. Has any condition that required systemic corticosteroid (equivalent to prednisone >10mg/d) or other immunosuppressive therapy within 28 days before informed consent. Patients received systemic corticosteroid equivalent to prednisone ≤10mg/d, inhale or topical corticosteroid will be allowed.
  7. Has received a live vaccine within 30 days before informed consent or will receive a live vaccine in the near future.
  8. Is pregnant or breastfeeding.
  9. Prior malignancy within 5 years, except in situ cancer, adequately treated non-melanoma skin cancer, and papillary thyroid carcinoma.
  10. Has known allergy to large molecule protein products or any compound of sintilimab.
  11. Has a known history of human immunodeficiency virus (HIV) infection.
  12. Any other condition, including symptomatic heart failure, unstable angina, myocardial infarction, active infection requiring systemic therapy, mental illness or domestic/social factors, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interferes with the interpretation of the results.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Intervention arm

    Patients will receive induction chemotherapy with gemcitabine (1g/m2, d1 \& 8 of every cycle) and cisplatin (80mg/m2, d1 of every cycle), every 3 weeks for 3 cycles before radiation. Definitive intensity-modulated radiotherapy (IMRT) of 66-70Gy will be given in six to seven weeks. Concurrent cisplatin 100mg/m2 will be administered every 3 weeks for 2 cycles during IMRT. Sintilimab 200mg will be given every 3 weeks for 6 cycles, started on day 1 of induction chemotherapy.

    Drug: Sintilimab · Drug: Gemcitabine · Drug: Cisplatin · Radiation: intensity-modulated radiotherapy

Interventions

  • DrugSintilimab

    Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles

    Also known as: IBI308, PD-1 antibody

  • DrugGemcitabine

    Gemcitabine 1g/m2, d1 \& 8 of every cycle, every 3 weeks for 3 cycles before radiation.

  • DrugCisplatin

    Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation

    Also known as: DDP

  • Radiationintensity-modulated radiotherapy

    Definitive IMRT of 66-70Gy will be given in six to seven weeks.

    Also known as: IMRT

06

What researchers measure

Primary outcomes

  1. Immune-related adverse events (irAEs) and serious adverse events (irSAEs)

    Graded according to CTCAE V5.0

    Time frame: From the date of informed consent to 100 days after treatment

  2. All adverse events (AEs) and serious adverse events (SAEs)

    Graded according to CTCAE V5.0

    Time frame: From the date of informed consent to 100 days after treatment

Secondary outcomes

  1. The proportion of patients who completed radiation within 8 weeks

    Time frame: 8 weeks

  2. The proportion of patients who completed 6 cycles of sintilimab

    Time frame: From the date of informed consent to the end of treatment, assessed up to 20 weeks.

  3. Failure-free survival

    calculated from the date of informed consent to the date of locoregional failure, distant failure, or death from any cause, whichever occurred first.

    Time frame: 3 years

  4. Overall survival

    calculated from the date of informed consent to the date of death from any cause.

    Time frame: 3 years

  5. Distant failure-free survival

    calculated from the date of informed consent to the date of distant metastasis.

    Time frame: 3 years

  6. Locoregional failure-free survival

    calculated from the date of informed consent to the the date of locoregional persistence or 1st locoregional recurrence.

    Time frame: 3 years

07

Study locations

1 site
  • SUN YAT-SEN UNIVERSITY cANCER CENTER
    Guangzhou, Guangdong 510060, China
08

References and documents

Publications

  • Li XM, Zhang XM, Li JY, Jiang N, Chen L, Tang LL, Mao YP, Li WF, Zhou GQ, Li YQ, Liu N, Zhang Y, Ma J. The immune modulation effects of gemcitabine plus cisplatin induction chemotherapy in nasopharyngeal carcinoma. Cancer Med. 2022 Sep;11(18):3437-3444. doi: 10.1002/cam4.4705. Epub 2022 Mar 30. PubMed 35355438 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03619824
Lead sponsor
Sun Yat-sen University
Collaborators
Innovent Biologics (Suzhou) Co. Ltd.
Responsible party
Jun Ma, MD (Professor, Sun Yat-sen University) — Principal investigator
First posted
Aug 8, 2018
Start date
Jan 2019 (estimated)
Primary completion
Oct 2019 (estimated)
Completion
Mar 2024 (estimated)
Last update
Oct 9, 2018

Study contacts

Jun Ma
Contact
majun2@mail.sysu.edu.cn
+862087343469
Jun Ma
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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