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Nasopharyngeal CarcinomaPhase 3NCT06675214

Under Whole-course of Immunotherapy, Gradient Fractionated RT with CCT Versus CFRT with CCT for LANPC Who Achieved PR Post Induction Chemotherapy.

A Phase 3 study testing Full course of PD-1/PD-L1 blockades, Cisplatin-based induction chemotherapy and Standard-dose IMRT in people with Nasopharyngeal Carcinoma and De-escalation Therapy, run by Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades… Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Full course of PD-1/PD-L1 blockades, Cisplatin-based induction chemotherapy and Standard-dose IMRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
586 participants
Where
1 siteChina
Study dates
30 Jul 2024to 31 Jul 2030
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 65 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).
  • Patients who achieved partial response according to the RECIST criteria on the basis of MRI, PET-CT and endoscopic biopsy after 3 cycles of induction therapy of platinum-based chemotherapy plus immunotherapy.
  • Eastern Cooperative Oncology Group performance status ≤1.
  • Age: 18-65 years old.
  • Adequate organ function:
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  • 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 CR or SD or PD 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.
  • The images of PET-CT and enhanced MRI/CT before induction chemotherapy showed necrotic foci in the center of primary tumors or regional lymph nodes.
  • The metabolic changes shown by PET-CT images after induction chemotherapy were inconsistent with the changes in the extent of tumor invasion shown by anatomical images such as enhanced MRI/CT.
  • The primary and/or cervical metastases of patients have received prior chemotherapy, immunotherapy, targeted therapy, or surgery (except diagnostic treatment).
  • Has a known history of hypersensitivity to any components of the PD-1/PD-L1 blockades formulation or other monoclonal antibodies.
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  • Has a known or suspected history of autoimmune diseases, including dementia and seizures.
  • Patients with recurrence, distant metastasis and other malignant tumors.
  • Severe heart disease, lung dysfunction, heart function, lung function below grade 3 (including grade 3)
  • Patients 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.
  • 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 allergic reactions to the drugs in the study (gemcitabine, cisplatin, docetaxel, abraxane, paclitaxel ).
  • 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.

Ming-Yuan Chen, MD,PhD contact

+86-20-87343361

chenmy@sysucc.org.cn

Rui You, MD,PhD contact

+86-13580439820

yourui@sysucc.org.cn

China1 site, 1 recruiting

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Ming-Yuan Chen, MD,PhD

    Recruiting

Other trials in China

About this study

Official title: Under Whole-course of Immunotherapy, Gradient Fractionated Radiotherapy with Concurrent Chemotherapy Versus Standard Fractionated Radiotherapy with Concurrent Chemotherapy for Locoregionally Advanced Nasopharyngeal Carcinoma Who Achieved Partial Response After Induction Chemotherapy: a Randomized, Open-label, Multicenter, Phase III Trial.

This prospective trial aims to enroll patients with stage III-IVA (AJCC 8th,) locoregionally advanced nasopharyngeal carcinoma (LANPC). Under the condition of full course of PD-1/PD-L1 blockades, patients who achieved radiological partial response after 3 cycles of platinum-based chemotherapy plus PD-1/PD-L1 blockades will be randomized in a 1:1 ratio to receive gradient radiotherapy (reducing the irradiation dose of PET-CT areas without metabolic abnormalities, while maintaining adequate irradiation dose of areas with metabolic abnormalities) or standard dose radiotherapy with concurrent chemotherapy. It is expected to provide a new therapeutic option for locally advanced nasopharyngeal carcinoma at moderate risk.

Being tested
Full course of PD-1/PD-L1 blockades, Cisplatin-based induction chemotherapy, Standard-dose IMRT, Gradient Fractionated 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.

  • Full course of PD-1/PD-L1 blockadesDrug

    1. 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.

  • Cisplatin-based induction chemotherapyDrug

    Cisplatin-based induction chemotherapy will be given every 3 weeks for 3 cycles before radiotherapy.

  • Standard-dose IMRTRadiation

    GTVnx/nd:69.96Gy/33Fr/2.12Gy CTV1: 60.60Gy/33Fr/1.82y CTV2: 54.12Gy/33Fr/1.64Gy

  • Gradient Fractionated IMRTRadiation

    GTVresidue: 68Gy/30Fr/2.27Gy GTVmcr: 60Gy/30F/2Gy CTV1:54Gy/30F/1.8Gy CTV2: 48GY/30F/1.60Gy

  • Concurrent ChemotherapyDrug

    Cisplatin 100mg/m2 every 3 weeks for 2 cycles

Study groups in NCT06675214
Study groupRoleWhat they receive
Induction chemotherapy plus conventional concurrent chemoradiotherapyActive comparatorNot described
Receives: Drug: Full course of PD-1/PD-L1 blockades; Drug: Cisplatin-based induction chemotherapy; Radiation: Standard-dose IMRT; Drug: Concurrent Chemotherapy
Induction chemotherapy plus gradient fractioned radiotherapy and concurrent chemotherapyExperimentalNot described
Receives: Drug: Full course of PD-1/PD-L1 blockades; Drug: Cisplatin-based induction chemotherapy; Radiation: Gradient Fractionated IMRT; Drug: Concurrent Chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  1. Overall Survival (OS)

    Defined as the time interval from randomization to death due to any cause.

    Measured: 3 years

  2. Locoregional Relapse-Free Survival (LRRFS)

    Defined as the time from randomisation to the date of first locoregional relapse.

    Measured: 3 years

  3. Distant Metastasis-Free Survival (DMFS)

    Defined as the time interval from randomisation to the date of first distant metastases.

    Measured: 3 years

  4. 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

  5. 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

  6. 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

  7. 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.

  1. First posted5 Nov 2024
  2. Study start30 Jul 2024
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Jul 2030 (estimated)

Resources

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
586 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06675214
Sponsor's protocol ID
ZDWY.BYAFZZX.074
Status last verified
Jul 2024
First submitted
3 Nov 2024
Last updated
5 Nov 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Full course of PD-1/PD-L1 blockades, Cisplatin-based induction chemotherapy and Standard-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 9 inclusion and 17 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 5 Nov 2024. 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?

On the ClinicalTrials.gov record for NCT06675214.

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 5 Nov 2024.

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