Nasopharyngeal CarcinomaPhase 3NCT04557020
Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC
A Phase 3 study testing PD-1 antibody, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma, run by Jiangxi Provincial Cancer Hospital at 7 sites in China.
Trial summary
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- PD-1 antibody, Gemcitabine and Cisplatin
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesChina
- Study dates
- 30 Dec 2020to 1 Mar 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Clinical staged as T4 or N3 （according to the 8th AJCC edition）
- No evidence of distant metastasis (M0)
- Male and no pregnant female
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
- WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
- Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
- Normal renal function test ( creatinine clearance ≥60 ml/min)
Who cannot join
- Recurrent or distant metastatic disease.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- History of radiotherapy or chemotherapy.
- History of immunodeficiency disease
- History of organ transplantation
- Presence of life-threatening illness
Show all 12Show fewer
- Uncontrolled hypercalcemia
- Severe uncontrolled medical conditions or active infectious diseases
- Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
- Pregnant or breastfeeding female
- Emotional disturbance or mental illness
- Refusal or inability to sign informed consent
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Shaojun Lin, MD, linshaojun@yeah.net
Shaojun Lin, MD
- Recruiting
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341000
Wei Wu, M.D.
Wei Wu, M.D.
- Recruiting
First Affiliated hospital of Gannan Medical University
Guangzhou, Jiangxi, 341000
Mingjun Xu, MD
Renwang Chen
- Recruiting
Jiujiang University Affiliated Hospital
Jiujiang, Jiangxi, 332000
Zhaohui Leng, MD
Zhaohui Leng, MD
- Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Xiaochang Gong, MD, 13970020755, gxcanddw@163.com
Xiaochang Gong, MD
- Recruiting
Pingxiang Peoples' Hospital
Pingxiang, Jiangxi, 330029
Fan Cai, MD
Fan Cai
- Recruiting
Suizhou Central Hospital
Suizhou, Hubei
Dongsheng Zhang, MD
Dongsheng Zhang
About this study
Official title: Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- PD-1 antibody, Gemcitabine, Cisplatin, IMRT
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PD-1 antibodyDrug
neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
GemcitabineDrug
neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
CisplatinDrug
neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT
IMRTRadiation
70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | IC with anti-PD1 mab+CCRT+anti-PD1 mab Receives: Drug: PD-1 antibody; Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT |
| Arm B | Active comparator | IC+CCRT Receives: Drug: Gemcitabine; Drug: Cisplatin; Radiation: IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-free survival (PFS)
From date of randomization to date of first documentation of progression or death due to any cause.
Measured: 3 year
Secondary outcomes (5)
Overall Survival (OS)
From date of randomization to date of first documentation of death from any cause or censored at the date of the last follow-up.
Measured: 3 year
Distant Metastasis-Free Survival (DMFS)
From date of randomization to date of first documentation of distant metastases or until the date of the last followup visit.
Measured: 3 year
Locoregional Relapse-Free Survival (LRRFS)
From date of randomization to date of first documentation of locoregional relapse or until the date of the last follow-up visit.
Measured: 3 year
Objective Response Rate （ORR）
Either a confirmed CR or a PR, as determined by the investigator using RECIST v1.1Response Evaluation Criteria in Solid Tumors (RECIST) from the National Cancer Institute (NCI).
Measured: within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
adverse events (AEs)
Treatment-related AEs (trAEs) and immune-related AEs (irAEs) according to the Common Terminology Criteria for Adverse Events, version 5.0
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2020
- Study start30 Dec 2020
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Mar 2026 (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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangxi Provincial Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jingao Li, M.D., Principal investigator, Jiangxi Provincial Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04557020
- Sponsor's protocol ID
- NPC2020-001
- Status last verified
- Feb 2024
- First submitted
- 2 Sep 2020
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adding Neoadjuvant and Adjuvant PD-1 Inhibitor to Neoadjuvant Chemotherapy Plus Concurrent Chemoradiotherapy in the Treatment of High-risk Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04557020
- Acronym / sponsor ID
- NPC2020-001
- Conditions
- Nasopharyngeal Carcinoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Jiangxi Provincial Cancer HospitalUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 21 Sep 2020 (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.
This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: PD-1 antibody, Drug: Gemcitabine, Drug: Cisplatin, Radiation: IMRTIC with anti-PD1 mab+CCRT+anti-PD1 mab |
| Arm B | Active comparator | Drug: Gemcitabine, Drug: Cisplatin, Radiation: IMRTIC+CCRT |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
- Clinical staged as T4 or N3 （according to the 8th AJCC edition）
- No evidence of distant metastasis (M0)
- Male and no pregnant female
- ECOG (Eastern Cooperative OncologyGroup) scale 0-1
Key exclusion criteria (12 listed)
- Recurrent or distant metastatic disease.
- History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
- History of radiotherapy or chemotherapy.
- History of immunodeficiency disease
- History of organ transplantation
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 |
|---|---|---|
| PD-1 antibodyneoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy | Drug | Arm A |
| Gemcitabineneoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles | Drug | Arm A, Arm B |
| Cisplatinneoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles. Concurrent chemoradiotherapy: Cisplatin 100mg/m2 in day 1, 22, and 43 during IMRT | Drug | Arm A, Arm B |
| IMRT70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions | Radiation | Arm A, Arm B |
Primary outcome
Progress-free survival (PFS)
Time frame: 3 year
From date of randomization to date of first documentation of progression or death due to any cause.
5 secondary outcomes
Overall Survival (OS)
Time frame: 3 year
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 year
Locoregional Relapse-Free Survival (LRRFS)
Time frame: 3 year
Objective Response Rate （ORR）
Time frame: within 3 weeks after neoadjuvant treatment and 3 months after concurrent chemoradiotherapy
adverse events (AEs)
Time frame: 3 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jingao Li, M.D. principal investigator
Jiangxi Provincial Cancer Hospital
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 PD-1 antibody, Gemcitabine and Cisplatin in people with Nasopharyngeal Carcinoma, run by Jiangxi Provincial Cancer Hospital 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 8 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: status not confirmed, as of the sponsor's last update on 1 May 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jingao Li (86-791-88300252, lijingao@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progress-free survival (PFS) (time frame: 3 year). 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 1 May 2024.