Nasopharyngeal CarcinomaPhase 3NCT04778956
Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma
A Phase 3 study testing Toripalimab and salvage surgery in people with Nasopharyngeal Carcinoma and PD-1, run by Sun Yat-sen University at 7 sites in China.
Trial summary
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, PD-1, Surgery
- What is being tested?
- Toripalimab and salvage surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 7 sitesChina
- Study dates
- 3 Mar 2021to 3 Mar 2033
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The recurrence time is more than 6 months from the end of radiotherapy.
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
- Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
- Given written informed consent.
Who cannot join
- Karnofsky Performance Status (KPS) ≤70.
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known subjects with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
- Suffered from diseases need long-term treatment with immunosuppressive drugs, or required systematic or local glucocorticoid therapy with immunosuppressive doses.
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- Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or cytotoxic T lymphocyte-associated antigen 4 (CTLA-4) agent.
- 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.
- Has a known history of human immunodeficiency virus (HIV), has hepatitis B surface antigen (HBsAg) positive with hepatitis B virus (HBV) DNA copy number of ≥1000cps/ml or hepatitis C virus (HCV) antibody positive.
- Has received a live vaccine within 4 weeks of planned start of study treatment.
- Pregnancy or breast feeding.
- Cannot complete regular follow-up.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD, PhD, 86-20-8734-3624, chmingy@mail.sysu.edu.cn
- Not yet recruiting
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510080
Wei-Ping Wen, MD, PhD, 86-13802966937, wenwp@mail.sysu.edu.cn
- Not yet recruiting
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Hao-Cheng Tang, MD.PhD, 86-15920115552, hctang2006@qq.com
- Not yet recruiting
The Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510700
Jian-Zhong Zhang, MD, 86-15820279737, 525567166@qq.com
- Not yet recruiting
The First People's Hospital of Foshan
Guangzhou, Guangdong, 528000
Jun Tang, MD, 86-18038860199, tjun@fsyyy.com
- Not yet recruiting
The Tenth Affiliated Hospital, Sun Yat-Sen University
Nanchang, Jiangxi, 330008
Ming-Yuan Chen, MD, PhD, 86-13903052650, chmingy@mail.sysu.edu.cn
- Not yet recruiting
Zhongshan People's Hospital
Zhongshan, Guangdong, 528403
Min-Yi Fu, 86-13924933366, 503498362@qq.com
About this study
Official title: Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Read the detailed description
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
- Conditions
- Nasopharyngeal Carcinoma, PD-1, Surgery
- Being tested
- Toripalimab, salvage surgery
- Keywords
- Nasopharyngeal carcinoma, Recurrent, Salvage surgery, Anti-programmed death-1 antibody, Disease free survival
- Medical subject headings
- Nasopharyngeal Carcinoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToripalimabDrug
Also called PD-1 antibody
Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
salvage surgeryProcedure or surgery
Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
| Study group | Role | What they receive |
|---|---|---|
| Toripalimab plus salvage surgery | Experimental | 1. Toripalimab: Toripalimab treatment before and after salvage surgery.
2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node. Receives: Drug: Toripalimab; Procedure: salvage surgery |
| Salvage surgery alone | Active comparator | 1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node. Receives: Procedure: salvage surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-free survival
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
Measured: 2 years
Secondary outcomes (7)
Objective Response Rate
Defined as the proportion of patients with radiologically confirmed complete or partial response according to RECIST 1.1.
Measured: 3-5 weeks
Major Pathological Response Rate
Defined as the proportion of patients with no more than 10% viable tumor cells which is identified on routine hematoxylin and eosin staining within the recurrent nasopharyngeal tumor and/or regional lymph node after neoadjuvant PD-1 treatment.
Measured: 4-6 weeks
Overall Survival
Defined as the time interval from randomization to death due to any cause.
Measured: 2 years
Distant Metastasis-Free Survival
Defined as the time interval from randomisation to the date of first distant metastases.
Measured: 2 years
Locoregional Relapse-Free Survival
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0) before treatment, during treatment, after treatment.
Measured: up to 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
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.
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start3 Mar 2021
- Primary completion3 Mar 2025 (estimated)
- Study completion3 Mar 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 218 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Tenth Affiliated Hospital, Sun Yat-sen University
- Responsible party
- Principal investigator, Ming-Yuan Chen, Sun Yat-sen University
- Investigators
- Ming-Yuan Chen, MD, PhD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778956
- Sponsor's protocol ID
- SYSUCC-CMY-2020-2302
- Status last verified
- Mar 2021
- First submitted
- 25 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toripalimab Plus Surgery vs Surgery Alone for Resectable Recurrent Nasopharyngeal Carcinoma: a Prospecitve, Parallel, Multicenter, Phase III, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04778956
- Acronym / sponsor ID
- SYSUCC-CMY-2020-2302
- Conditions
- Nasopharyngeal Carcinoma, PD-1, Surgery
- Keywords
- Nasopharyngeal carcinoma, Recurrent, Salvage surgery, Anti-programmed death-1 antibody, Disease free survival
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 218 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, First People's Hospital of Foshan, Zhongshan People's Hospital, Guangdong, China, Tenth Affiliated Hospital, Sun Yat-sen University
- Study start
- 3 Mar 2021 (actual)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 3 Mar 2033 (estimated)
- First posted
- 3 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that PD-1 treatment added to salvage surgery could further decrease the rate of disease progression and improve the survival outcome of patients with resectable locally recurrent nasopharyngeal carcinoma compared with those treated with salvage surgery alone.
Detailed description
Through multicenter, open-label, randomised clinical trials, patients with resectable locally recurrent nasopharyngeal carcinoma are randomized into salvage surgery plus PD-1 treatment group and salvage surgery alone group. The efficacy and safety of patients between these two groups are compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Toripalimab plus salvage surgery | Experimental | Drug: Toripalimab, Procedure: salvage surgery1. Toripalimab: Toripalimab treatment before and after salvage surgery. 2. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node. |
| Salvage surgery alone | Active comparator | Procedure: salvage surgery1. Salvage surgery: endoscopic nasopharyngectomy for recurrent nasopharyngeal tumor, and selective neck dissection for recurrent regional lymph node. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The recurrence time is more than 6 months from the end of radiotherapy.
- Histologically confirmed recurrent nasopharyngeal carcinoma.
- Resectable nasopharyngeal diseases: recurrent T1 (the tumor is confined in nasopharynx, oropharynx and/or nasal cavity without parapharyngeal involvement); recurrent T2 (the tumor is confined in the superficial parapharyngeal spacer and is more than 0.5cm far from the internal carotid artery) and recurrent T3 (the tumor is confined in the base wall of the sphenoid sinus and is more than 0.5cm far from the internal carotid artery and cavernous sinus). (according to the 8th edition of American Joint Committee on Cancer (AJCC) staging system for nasopharyngeal carcinoma)
- Resectable recurrent regional lymph node diseases (recurrent N1-3) without prevertebral fascia, cervical vertebrae, or common/internal carotid artery involvement. (according to the 8th edition of AJCC staging system)
- Given written informed consent.
Key exclusion criteria (12 listed)
- Karnofsky Performance Status (KPS) ≤70.
- Has severe medical disorder, important organ dysfunction, and/or a substantial history of mental illness.
- Has known subjects with other malignant tumors.
- Has participated in other drug trials within 3 months of planned start of study treatment.
- Received a systematic or local glucocorticoid therapy within 4 weeks of planned start of study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToripalimabAlso: PD-1 antibodyToripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year. | Drug | Toripalimab plus salvage surgery |
| salvage surgeryEndoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node. | Procedure or surgery | Salvage surgery alone, Toripalimab plus salvage surgery |
Primary outcome
Disease-free survival
Time frame: 2 years
Defined as the time interval from randomization to disease progression or death due to any cause, whichever come first.
7 secondary outcomes
Objective Response Rate
Time frame: 3-5 weeks
Major Pathological Response Rate
Time frame: 4-6 weeks
Overall Survival
Time frame: 2 years
Distant Metastasis-Free Survival
Time frame: 2 years
Locoregional Relapse-Free Survival
Time frame: 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: up to 2 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ming-Yuan Chen, MD, PhD principal investigator
Sun Yat-sen University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toripalimab and salvage surgery in people with Nasopharyngeal Carcinoma and PD-1, run by Sun Yat-sen University at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ming-Yuan Chen, MD, PhD (86-20-87343624, chmingy@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-free survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2021.