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Oligometastatic DiseasePhase 2NPC-CR01NCT05128201

Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma

A Phase 2 study testing consolidative radiotherapy in people with Oligometastatic Disease, run by Jiangxi Provincial Cancer Hospital at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Oligometastatic Disease
What is being tested?
consolidative radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
63 participants
Where
3 sitesChina
Study dates
1 Dec 2021to 31 May 2026
Phase
Phase 2
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. 18-70 years old, no gender limit;
  • 2. Oligo metastasis is defined as less than or equal to 5 metastatic lesions and less than or equal to 2 metastatic organs
  • 3. Patients with an ECOG score of 0 or 1, and an expected survival period of ≥6 months;
  • 4. Has good organ function:
  • Hematology: WBC>3.0×109/L; ANC>1.5×109/L; Hb>90g/L; PLT>100×109/L; Albumin ≥3g/dL;
  • Liver function: bilirubin ≤ 1.5 times the upper limit of normal (ULN) (patients with known Gilbert disease and serum bilirubin level ≤ 3 times ULN can be included), AST and ALT ≤ 3 times ULN (if liver metastases occur , Then AST/ALT≤5 times ULN), and alkaline phosphatase≤3 times ULN (if liver or bone metastasis occurs, ALP≤5 times ULN); （3） Coagulation function: International normalized ratio (INR) or prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; （4）Renal function: According to the Cockcroft-Gault formula (Appendix 8), serum creatinine ≤1.5 times ULN or creatinine clearance ≥60mL/min.
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  • 5. Female subjects have a negative pregnancy test (for female patients with fertility); female patients without fertility;
  • 6. Male patients with fertility and female patients with fertility and risk of pregnancy must agree to take adequate contraceptive measures throughout the study period, and contraception lasts for 12 months after receiving this program.
  • 7. Patients who are willing and able to comply with visit arrangements, treatment plans, laboratory tests and other research procedures;
  • 8. During the research period, they are willing to comply with the arrangement and cannot participate in any other clinical research on drugs and medical devices;
  • 9. For patients who have previously received neoadjuvant chemotherapy, adjuvant chemotherapy, radiotherapy or radiotherapy for non-metastatic diseases, the time from the last chemotherapy and/or radiotherapy to randomization must reach a non-treatment interval of ≥ 6 months . Oral S1 and capecitabine have no requirement for treatment interval for those who are progressing during chemotherapy.
  • 10. The patients sign a formal informed consent form to show that they understand that this study complies with the hospital's policies

Who cannot join

  • 1. Those who have a history of severe immediate hypersensitivity to any of the drugs used in this study;
  • 2. Suffered from other malignant tumors other than nasopharyngeal carcinoma within 5 years (except for tumors with an expected 5-year OS>90%, such as non-melanoma skin cancer or pre-invasive cervical cancer);
  • 3. Any of the following conditions in the 6 months before screening: myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient cerebral ischemia Onset or symptomatic pulmonary embolism. Patients with known coronary artery disease, congestive heart failure that does not meet the above criteria, or left ventricular ejection fraction <50% must adopt an optimized and stable medical plan determined by the treating doctor. If appropriate, you can consult a cardiologist;
  • 4. Have received any of the following treatments:
  • Have received anti-PD-1 or anti-PD-L1 antibody therapy in the past;
  • Have received any investigational drug within 4 weeks before using the investigational drug for the first time;
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  • A large number of glucocorticoids or other immunosuppressants (including but not limited to prednisone, dexamethasone, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor) have been used in the 4 weeks before treatment Subjects with anti-TNF drugs, or subjects in need of hormone therapy during clinical trials. Other special circumstances require communication with the sponsor. In the absence of active autoimmune diseases, inhaled or topical steroids and adrenal cortex hormones with a dose> 10 mg/day of prednisone are allowed to be substituted;
  • Those who have been vaccinated with anti-tumor vaccines or the study drug has been vaccinated with live vaccines within 4 weeks before the first administration;
  • Have undergone major surgery or severe trauma within 4 weeks before using the study drug for the first time;
  • Enroll in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or an interventional clinical study follow-up;
  • 5. Patients with active autoimmune disease or a history of autoimmune disease but may relapse. Remarks: Patients with the following diseases are not excluded and can enter further screening:
  • Controlled type 1 diabetes
  • Hypothyroidism (if only hormone replacement therapy can be used to control)
  • Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis, hair loss)
  • Any other diseases that are not expected to recur without external triggers
  • 6. Active infections, including tuberculosis, hepatitis B, hepatitis C and human immunodeficiency virus. Patients with positive HBV surface antigen (HBsAg) but HBV DNA <1000 copies/mL are eligible to participate in this study; patients with positive HCV antibody test results are only allowed if the HCV RNA polymerase chain reaction test results are negative. Be selected for this study;
  • 7. Idiopathic pulmonary fibrosis, drug-induced pneumonia, organizing pneumonia (bronchiolitis obliterans), idiopathic pneumonia, or chest CT scan at the time of screening shows evidence of active pneumonia;
  • 8. Drug abuse or alcohol addiction;
  • 9. No capacity for civil conduct or limited capacity for civil conduct;
  • 10. The patient has a physical or mental illness, and the researcher believes that the patient cannot fully or fully understand the possible complications of this study;
  • 11. Other serious acute or chronic medical conditions (including immune colitis, inflammatory diseases, Enteropathy, non-infectious pneumonia, pulmonary fibrosis) or mental illness (including dementia and epilepsy, recent, past year or active suicidal ideation or behavior) or abnormal laboratory tests;
  • 12. Patients whose expected survival time is less than 6 months;
  • 13. Patients with significantly reduced heart, liver, lung, kidney and bone marrow functions
  • 14. Previously diagnosed as immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases;
  • 15. Female patients during pregnancy or lactation, male or female patients who are fertile but are unwilling or unable to use contraception during the entire study period and at least one year after the end of the treatment plan;

Trial locations and contacts

3 sites in 1 country.

China3 sites, 3 recruiting

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350011

    Shaojun Lin, MD, 13860603879, linshaojun@yeah.net

    Qiaojuan Guo, PhD, 15080013157, guoqiaojuan@163.com

    Recruiting

  • Ganzhou Cancer Hospital

    Ganzhou, Jiangxi

    Wei Wu, MD, 13970112033, wuweimingzi@163.com

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330029

    Jingao Li, MD, 8613970866296, lijingao@hotmail.com

    Xiaochang Gong, MD, 8613970020755, gxcanddw@163.com

    Recruiting

Other trials in China

About this study

Official title: Consolidative Radiotherapy Combined With Camrelizumab and Chemotherapy for Oligometastatic Nasopharyngeal Carcinoma: A Multicenter, Open-Label, Phase II Trial (NPC-CR01)

The purpose of this study is to explore the efficacy and tolerance of local consolidative radiotherapy combined with Camrelizumab and chemotherapy in patients with oligometastatic nasopharyngeal carcinoma

Read the detailed description

This trial was a single-arm, multicenter phase Ⅱ clinical study. Eligible oligometastatic NPC patients were scheduled to evaluate the efficacy and tolerance of local consolidative radiotherapy combined with camrelizumab and chemotherapy in patients with oligometastatic NPC. Progression-free survival (PFS) determined will be the primary outcome measures.

Being tested
consolidative radiotherapy
Keywords
local consolidative radiotherapy, oligometastatic nasopharyngeal carcinoma, Progression-free survival, immune checkpoint inhibitor

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • consolidative radiotherapyRadiation

    Also called local consolidative radiotherapy

    local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F)

Study groups in NCT05128201
Study groupRoleWhat they receive
System treatment plus consolidative radiotherapy and Maintenance treatmentExperimental4-6 Cycles System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) ; And local consolidative radiotherapy for all metastatic lesion (30-45Gy/3-8F) and Maintenance of Camrelizumab (total 2 years; from first cycles of System chemotherapy to last cycles of miantenance of camrelizumab)
Receives: Radiation: consolidative radiotherapy

What is being measured

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

  1. Progression-free survival

    The time from the start of treatment to the first observation of disease progression or death from any cause (whichever occurs first)

    Measured: 2 years

Secondary outcomes (4)

  1. Objective response rate (ORR)

    the proportion of patients achieving the optimal overall remission (complete or partial remission)

    Measured: 2 years

  2. Disease control rate (DCR)

    the proportion of patients with the best efficacy (CR or PR or SD)

    Measured: 2 years

  3. Overall survival (OS)

    the time from the start of treatment to death from any cause

    Measured: 3 years

  4. Duration of Overall Response (DOR)

    the time the patient first reaches complete or partial remission to disease progression

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2021
  2. Study start1 Dec 2021
  3. Primary completion31 May 2025 (estimated)
  4. Study completion31 May 2026 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
System chemotherapy (Camrelizumab , Gemcitabine and cisplatin or nedaplatin) And local consolidative radiotherapy for all metastatic lesion, and Maintenance of Camrelizumab
Masking
None (open label)
Enrolment
63 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05128201
Sponsor's protocol ID
NPC-CR01
Other IDs
2020-PT320-004
Acronym
NPC-CR01
Status last verified
Apr 2024
First submitted
6 Nov 2021
Last updated
30 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: After completing the treatment plan, we will report our research plan and research results.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing consolidative radiotherapy in people with Oligometastatic Disease, run by Jiangxi Provincial Cancer Hospital at 3 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 12 inclusion and 25 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 30 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-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?

On the ClinicalTrials.gov record for NCT05128201.

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 30 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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