Nasopharyngeal CarcinomaPhase 3NCT06092957
Reduced-dose RT With/Without CCT Versus Standard CCRT for High-risk LANPC Who Achieved CR Post Induction Chemotherapy
A Phase 3 study testing Cisplatin-based induction chemotherapy, Full course of PD-1/PD-L1 blockades and Reduced-dose IMRT in people with Nasopharyngeal Carcinoma and De-escalation Therapy, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma, De-escalation Therapy
- What is being tested?
- Cisplatin-based induction chemotherapy, Full course of PD-1/PD-L1 blockades and Reduced-dose IMRT
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2023to 30 Oct 2031
- 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
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Tumor staged as III-IVA (AJCC 8th, except T3N0).
- Patients who achieved both radiological and biological CR according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy, and EBV DNA load =0 copies/mL (or lower than the test line) after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
- Eastern Cooperative Oncology Group performance status ≤1.
- Adequate organ function:
- Adequate marrow function: neutrocyte count≥4×10e9/L, hemoglobin ≥90g/L and platelet count ≥100×10e9/L.
- Adequate liver and kidney function: Alanine Aminotransferase (ALT)/Aspartate Aminotransferase (AST) ≤2.5×upper limit of normal (ULN), and bilirubin ≤ 2.5×ULN.; creatinine clearance rate ≥ 60 ml/min or creatinine of no more than 1.5 times the upper normal limit.
- Patients must be informed of the investigational nature of this study and give written informed consent.
Who cannot join
- Patients who are evaluated as PR or SD or PD or EBV DNA load of >0 copies/mL after 3 cycles of induction therapy of platinum-based chemotherapy plus PD-1/PD-L1 blockades.
- The laboratory examination value does not meet the relevant standards within 7 days before enrollment.
- Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment).
- Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
- Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease).
- Grade ≥2 epistaxis (defined as the need for medical intervention such as nasal tamponade, cautery, topical vasoconstrictors, according to CTCAE 5.0) within 1 month prior to enrollment; Macroscopic hemoptysis or hematemesis) is defined as ≥1/2 teaspoon of bright red blood, or a blood clot with little/no sputum on each cough). (Patients with mixed sputum-blood occasionally may be enrolled).
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- Patients with hypertension who cannot be reduced to the normal range by antihypertensive drug treatment (systolic blood pressure > 140 mmHg/diastolic blood pressure > 90 mmHg), patients with ≥ grade II coronary heart disease, arrhythmia (including QTc interval prolongation > 450 ms in men and > 470 ms in women) and cardiac insufficiency.
- Patients currently take warfarin, heparin, aspirin (> 325 mg/day) or other NSAIDs known to inhibit platelet function, ticlopidine, clopidogrel, or cilostazol. (Patients can be enrolled if they discontinue these drugs 10 days prior to the commence of study and meet the requirements of coagulation in the enrollment criteria).
- Patients with other malignancies (except for cervical cancer, basal cell carcinoma or squamous cell carcinoma of the skin, localized prostate cancer, and ductal carcinoma in situ who have undergone curative treatment).
- Has a known history of interstitial lung disease.
- Known history of hypersensitivity to any components of the PD-1/PD-L1 blockades formulation or other monoclonal antibodies.
- Has a known history of allergic reactions to the drugs in the study (gemcitabine, cisplatin, docetaxel, abraxane, paclitaxel ).
- Has active autoimmune disease or any condition that requires systemic corticosteroid or immunosuppressive therapy, including but not limited to the following: rheumatoid arthritis, pneumonitis, colitis (inflammatory bowel disease), hepatitis, hypophysitis, nephritis, hyperthyroidism, and hypothyroidism, except for subjects with vitiligo or resolved childhood asthma/atopy. Subjects with the following conditions will not be excluded from this study: asthma that requires intermittent use of bronchodilators, hypothyroidism stable on hormone replacement, vitiligo, Graves' disease, or Hashimoto's disease. Additional exceptions may be made with medical monitor approval.
- Complications requiring long-term use of immunosuppressive drugs or systemic or local use of immunosuppressive-dose corticosteroids.
- HIV positive; HBsAg positive and HBV DNA copy number positive (quantitative detection ≥ 1000 cps/ml); chronic hepatitis C with blood screening positive (HCV antibody positive).
- Has a known history of active TB (bacillus tuberculosis) within 1 year; anti-TB treatment is ongoing or within 1 year prior to screening.
- Has received a live vaccine; or a systematic glucocorticoid therapy ; or any anti-infective vaccine (e.g. influenza vaccine, varicella vaccine, etc.) ; any Chinese anti-tumor herbs within 4 weeks prior to enrollment.
- Pregnancy or breastfeeding.
- Other patients who were considered unsuitable by the treating physicians.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Ming-Yuan Chen, MD,PhD
About this study
Official title: Reduced-dose Radiotherapy With/Without Concurrent Chemotherapy Versus Standard Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Complete Response After Induction Chemotherapy Plus Immunotherapy: a Randomized, Open-label, Multicenter, Phase III Trial
This prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
- Conditions
- Nasopharyngeal Carcinoma, De-escalation Therapy
- Being tested
- Cisplatin-based induction chemotherapy, Full course of PD-1/PD-L1 blockades, Reduced-dose IMRT, Standard-dose IMRT, Concurrent Chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cisplatin-based induction chemotherapyDrug
Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen.
Full course of PD-1/PD-L1 blockadesDrug
- Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment.
Reduced-dose IMRTRadiation
GTVnx:60Gy/30F/2.0Gy，CTV1:54Gy/30F/1.8Gy，CTV2:48Gy/30F/1.6Gy
Standard-dose IMRTRadiation
GTVnx：69.96Gy/33Fr/2.12Gy；CTV1：60.60Gy/33Fr/1.82y；CTV2：54.12Gy/33Fr/1.64Gy
Concurrent ChemotherapyDrug
Cisplatin 100mg/m2 every 3 weeks for 2 cycles
| Study group | Role | What they receive |
|---|---|---|
| Induction chemotherapy plus conventional concurrent chemoradiotherapy | Active comparator | Not described Receives: Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1/PD-L1 blockades; Radiation: Standard-dose IMRT; Drug: Concurrent Chemotherapy |
| Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy | Experimental | Not described Receives: Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1/PD-L1 blockades; Radiation: Reduced-dose IMRT; Drug: Concurrent Chemotherapy |
| Induction chemotherapy plus reduced-dose radiotherapy alone | Experimental | Not described Receives: Drug: Cisplatin-based induction chemotherapy; Drug: Full course of PD-1/PD-L1 blockades; Radiation: Reduced-dose IMRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progress-Free Survival (PFS)
Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.
Measured: 3 years
Secondary outcomes (7)
Overall Survival (OS)
Defined as the time interval from randomization to death due to any cause.
Measured: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Defined as the time from randomisation to the date of first locoregional relapse.
Measured: 3 years
Distant Metastasis-Free Survival (DMFS)
Defined as the time interval from randomisation to the date of first distant metastases.
Measured: 3 years
The proportion of patients with treatment related acute complications
The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: 1 year
The proportion of patients with treatment related late complications
The proportion of patients with treatment related late complications according to NCI-CTC5.0 criteria and RTOG criteria.
Measured: 3 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: 3 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: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start9 Oct 2023
- Primary completion30 Oct 2029 (estimated)
- Study completion30 Oct 2031 (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
- 504 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, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, The fifth Affiliated Hospital of Guangzhou Medcial University, Zhongshan People's Hospital, Guangdong, China, Hunan Cancer Hospital, Tongji Hospital
- 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
- NCT06092957
- Sponsor's protocol ID
- SYSUCC-CMY-2023-09-25
- Status last verified
- Dec 2023
- First submitted
- 16 Oct 2023
- Last updated
- 15 Dec 2023
- 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 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced-dose Radiotherapy With/Without Concurrent Chemotherapy Versus Standard Chemoradiotherapy for High-risk Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Complete Response After Induction Chemotherapy Plus Immunotherapy: a Randomized, Open-label, Multicenter, Phase III Trial
- ClinicalTrials.gov ID
- NCT06092957
- Acronym / sponsor ID
- SYSUCC-CMY-2023-09-25
- Conditions
- Nasopharyngeal Carcinoma, De-escalation Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 504 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Provincial People's Hospital, Second Affiliated Hospital, Sun Yat-Sen University, The fifth Affiliated Hospital of Guangzhou Medcial University, Zhongshan People's Hospital, Guangdong, China, Hunan Cancer Hospital, Tongji Hospital
- Study start
- 9 Oct 2023 (actual)
- Primary completion
- 30 Oct 2029 (estimated)
- Study completion
- 30 Oct 2031 (estimated)
- First posted
- 23 Oct 2023 (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 prospective trial aims to enroll patients with high-risk stage III-IVA (AJCC 8th, except T3N0) locoregionally-advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved both radiological and biological complete response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1:1 ratio to receive reduced-dose radiotherapy (60Gy/30F) alone or reduced-dose radiotherapy plus concurrent chemotherapy or standard dose radiotherapy (70Gy/33F) with concurrent chemotherapy. To solve the urgent problem of whether patients with high-risk advanced nasopharyngeal carcinoma are suitable for downgrade treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Induction chemotherapy plus conventional concurrent chemoradiotherapy | Active comparator | Drug: Cisplatin-based induction chemotherapy, Drug: Full course of PD-1/PD-L1 blockades, Radiation: Standard-dose IMRT, Drug: Concurrent Chemotherapy |
| Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy | Experimental | Drug: Cisplatin-based induction chemotherapy, Drug: Full course of PD-1/PD-L1 blockades, Radiation: Reduced-dose IMRT, Drug: Concurrent Chemotherapy |
| Induction chemotherapy plus reduced-dose radiotherapy alone | Experimental | Drug: Cisplatin-based induction chemotherapy, Drug: Full course of PD-1/PD-L1 blockades, Radiation: Reduced-dose IMRT |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).
- Tumor staged as III-IVA (AJCC 8th, except T3N0).
- Patients who achieved both radiological and biological CR according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy, and EBV DNA load =0 copies/mL (or lower than the test line) after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
- Eastern Cooperative Oncology Group performance status ≤1.
- Adequate organ function:
Key exclusion criteria (19 listed)
- Patients who are evaluated as PR or SD or PD or EBV DNA load of >0 copies/mL after 3 cycles of induction therapy of platinum-based chemotherapy plus PD-1/PD-L1 blockades.
- The laboratory examination value does not meet the relevant standards within 7 days before enrollment.
- Patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (other than diagnostic treatment).
- Subjects who underwent anti-PD-1 /PD-L1 antibody or anti-CTLA-4 antibody (or any other antibody acting on T cell synergistic stimulation or checkpoint pathway) and anti-angiogenic drugs.
- Active central nervous system (CNS) metastases (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive disease).
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 |
|---|---|---|
| Cisplatin-based induction chemotherapyCisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy including GP, TP, and TPF regimen. | Drug | Induction chemotherapy plus conventional concurrent chemoradiotherapy, Induction chemotherapy plus reduced-dose radiotherapy alone, Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy |
| Full course of PD-1/PD-L1 blockadesa) Camrelizumab 200mg, b) Toripalimab 240mg, or c) Adebrelimab 1200mg will be started on day 1 of induction chemotherapy and given every 3 weeks for up to 12 cycles, or until intolerable toxicity, or disease progression or withdrawal from the treatment. | Drug | Induction chemotherapy plus conventional concurrent chemoradiotherapy, Induction chemotherapy plus reduced-dose radiotherapy alone, Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy |
| Reduced-dose IMRTGTVnx:60Gy/30F/2.0Gy，CTV1:54Gy/30F/1.8Gy，CTV2:48Gy/30F/1.6Gy | Radiation | Induction chemotherapy plus reduced-dose radiotherapy alone, Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy |
| Standard-dose IMRTGTVnx：69.96Gy/33Fr/2.12Gy；CTV1：60.60Gy/33Fr/1.82y；CTV2：54.12Gy/33Fr/1.64Gy | Radiation | Induction chemotherapy plus conventional concurrent chemoradiotherapy |
| Concurrent ChemotherapyCisplatin 100mg/m2 every 3 weeks for 2 cycles | Drug | Induction chemotherapy plus conventional concurrent chemoradiotherapy, Induction chemotherapy plus reduced-dose radiotherapy and concurrent chemotherapy |
Primary outcome
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.
7 secondary outcomes
Overall Survival (OS)
Time frame: 3 years
Locoregional Relapse-Free Survival (LRRFS)
Time frame: 3 years
Distant Metastasis-Free Survival (DMFS)
Time frame: 3 years
The proportion of patients with treatment related acute complications
Time frame: 1 year
The proportion of patients with treatment related late complications
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire (QLQ)-C30 (V3.0)
Time frame: 3 years
Score of survival quality according to the EORTC Quality of Life Questionnaire Head and Neck (The QLQ-H&N35)
Time frame: 3 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 15 Dec 2023.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cisplatin-based induction chemotherapy, Full course of PD-1/PD-L1 blockades and Reduced-dose IMRT in people with Nasopharyngeal Carcinoma and De-escalation Therapy, run by Sun Yat-sen University at 1 site 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 19 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 15 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 (+86-20-87343361, chenmy@sysucc.org.cn), 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 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 15 Dec 2023.