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Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04453826
Recruitment Status : Recruiting
First Posted : July 1, 2020
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongshan People's Hospital, Guangdong, China
Yuebei People's Hospital
Wuzhou Red Cross Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Ming-Yuan Chen, Sun Yat-sen University

Brief Summary:
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Cancer Chemotherapy Radiotherapy PD-1 Therapy Drug: Camrelizumab plus chemo-radiotherapy Drug: Chemo-radiotherapy alone Phase 3

Detailed Description:
Through multicenter, open-label, randomised clinical trials, high risk patients with nasopharyngeal carcinoma (staged as II-III with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy and staged as IVa) are randomized into camrelizumab plus chemo-radiotherapy arm and chemo-radiotherapy arm. The efficacy and safety of patients between these two arms are compared.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized Clinical Phase 3 Trial of Induction Chemotherapy Plus Concurrent Chemo-radiotherapy With or Without Camrelizumab for High Risk Nasopharyngeal Carcinoma
Actual Study Start Date : September 1, 2020
Estimated Primary Completion Date : September 2026
Estimated Study Completion Date : September 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Camrelizumab plus chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy with concurrent and adjuvant camrelizumab therapy.
Drug: Camrelizumab plus chemo-radiotherapy
  1. Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy.
  2. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
  3. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
  4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

Active Comparator: Chemo-radiotherapy arm
3 cycles of gemcitabin and cisplatin induction chemotherapy plus concurrent chemo-radiotherapy.
Drug: Chemo-radiotherapy alone
  1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
  2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
  3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy




Primary Outcome Measures :
  1. Progress-free survival (PFS) [ Time Frame: 3 years ]
    Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 3 years ]
    Defined as the time interval from randomization to death due to any cause.

  2. Distant Metastasis-Free Survival (DMFS) [ Time Frame: 3 years ]
    Defined as the time interval from randomisation to the date of first distant metastases.

  3. Locoregional Relapse-Free Survival (LRRFS) [ Time Frame: 3 years ]
    Defined as the time from randomisation to the date of first locoregional relapse.

  4. Incidence of treatment related acute complications [ Time Frame: up to 1 years ]
    The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

  5. Incidence of treatment related late complications [ Time Frame: up to 3 years ]
    The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.

  6. Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) [ Time Frame: up to 3 years ]
    Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.

  7. Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) [ Time Frame: up to 3 years ]
    Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35) before treatment, during treatment, after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
  2. Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).
  3. Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy.
  4. Aged between 18-70 years.
  5. Karnofsky scale (KPS)≥70.
  6. Normal bone marrow function.
  7. Normal liver and kidney function:

    1. total bilirubin, AST and ALT levels of no more than 2.5 times the upper normal limit;
    2. creatinine clearance rate of at least 60 mL/min or creatinine of no more than 1.5 times the upper normal limit.
  8. Given written informed consent.

Exclusion Criteria:

  1. Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.
  2. Recurrent or metastatic nasopharyngeal carcinoma.
  3. Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.
  4. Has known allergy to large molecule protein products or any compound of study therapy.
  5. Has known subjects with other malignant tumors.
  6. Has any active autoimmune disease or history of autoimmune disease.
  7. Has a history of psychiatric substance abuse, alcoholism, or drug addiction.
  8. The laboratory examination value does not meet the relevant standards within 7 days before enrollment
  9. Received a systematic glucocorticoid therapy within 4 weeks of the first dose of study medication.
  10. Has a known history of active TB (bacillus tuberculosis) within 1 year; patients with adequately treated active TB with 1 year.
  11. Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent.
  12. Has active autoimmune disease (e.g., uveitis, enteritis, hepatitis, hypophysitis, nephritis, vasculitis, hyperthyroidism, and asthma requiring bronchodilator therapy). Patients with skin disease that doesn't require systemic treatment (e.g., vitiligo, psoriasis, or alopecia) will be allowed to enroll.
  13. Has a known history of human immunodeficiency virus (HIV).
  14. Has hepatitis B surface antigen (HBsAg) positive with HBV DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
  15. Has received a live vaccine within 4 weeks of planned start of study therapy.
  16. Pregnancy or breast feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04453826


Contacts
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Contact: Ming-Yuan Chen, MD, PhD : 86-20-87343624 chmingy@mail.sysu.edu.cn
Contact: Rui You, MD, PhD 86-13580439820 yourui@sysucc.org.cn

Locations
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China, Guangdong
Sun Yat-sen University Cancer Center Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Ming-Yuan Chen, MD, PhD    86-20-8734-3361    chmingy@mail.sysu.edu.cn   
Principal Investigator: Ming-Yuan Chen, MD, PhD         
Cancer Center of Guangzhou Medical University Not yet recruiting
Guangzhou, Guangdong, China, 510095
Contact: Dong-Ping Chen, MD    86-13302215492    chen_dpgz@163.com   
Principal Investigator: Dong-Ping Chen, MD         
Yuebei People's Hospital Not yet recruiting
Shaoguan, Guangdong, China, 512025
Contact: Su-Ming Pan, MD    86-13826331948      
Principal Investigator: Su-Ming Pan, MD         
Zhongshan People's Hospital Recruiting
Zhongshan, Guangdong, China, 528403
Contact: Feng Lei, MD       13528227676@163.com   
Principal Investigator: Feng Lei, MD         
The Fifth Affiliated Hospital of Sun Yat-sen University Recruiting
Zhuhai, Guangdong, China, 519000
Contact: Zhi-Gang Liu, MD, PhD    86-18627585860      
Principal Investigator: Zhi-Gang Liu, MD, PhD         
China, Guangxi
Wuzhou Red Cross Hospital Not yet recruiting
Wuzhou, Guangxi, China, 543002
Contact: Jin-Hui Liang, MD    86-13878480806      
Principal Investigator: Jin-Hui Liang, MD         
Sponsors and Collaborators
Sun Yat-sen University
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Zhongshan People's Hospital, Guangdong, China
Yuebei People's Hospital
Wuzhou Red Cross Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
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Responsible Party: Ming-Yuan Chen, Professor, Chief Doctor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT04453826    
Other Study ID Numbers: SYSUCC-MYC-2020-1103
First Posted: July 1, 2020    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nasopharyngeal Carcinoma
Nasopharyngeal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases