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Nasopharyngeal NeoplasmsPhase 2NCT06688175

IMRT Combined With Lobaplatin-based CCRT in Nasopharyngeal Carcinoma

A Phase 2 study testing IMRT combined with lobaplatin-based concurrent chemotherapy in people with Nasopharyngeal Neoplasms and Elderly, run by The First Affiliated Hospital of Xiamen University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma Read more about this study

Who is it for?
Ages 65 to 80 years
Conditions the study is for
Nasopharyngeal Neoplasms, Elderly, Chemotherapy
What is being tested?
IMRT combined with lobaplatin-based concurrent chemotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteChina
Study dates
13 Nov 2024to 31 Dec 2027
Phase
Phase 2
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 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Pathologically confirmed differentiated non-keratinizing carcinoma and undifferentiated non-keratinizing carcinoma;
  • Stage II-IVa (UICC 8th edition);
  • Acceptable induction chemotherapy and Tarceva targeted therapy;
  • No history of other malignant tumors;
  • Male or female, aged 65-80 years.
  • Liver function: Total bilirubin ≤ Upper Limit of Normal (ULN); AST and ALT ≤ 2.5 times ULN; Alkaline phosphatase ≤ 5 times ULN;
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  • Renal function: Creatinine clearance ≥ 60 ml/min or Creatinine ≤ 1.5 × ULN;
  • Hematological tests: Absolute Neutrophil Count (ANC) ≥ 2 × 10^9/L, Platelet count ≥ 100 × 10^9/L, and Hemoglobin ≥ 9 g/dL;
  • No severe dysfunction of vital organs such as heart and lung;
  • PS score ≤ 2 points

Who cannot join

  • Distant metastases detected before treatment;
  • Refusal to sign the informed consent form;
  • Patients who cannot comply with regular follow-up due to psychological, social, family, or geographical reasons;
  • Simultaneously receiving other experimental treatments in clinical trials (during the treatment phase of clinical research);
  • Severe, uncontrolled infections or medical conditions;
  • Vital organ dysfunction, decompensated heart, lung, kidney, or liver failure, unable to tolerate radiotherapy and chemotherapy;
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  • Laboratory tests: Total bilirubin > Upper Limit of Normal (ULN); AST and/or ALT > 1.5 times ULN with alkaline phosphatase > 2.5 times ULN;
  • Factors affecting drug administration, distribution, metabolism, and excretion, such as mental abnormalities, central nervous system abnormalities, chronic diarrhea, ascites, pleural effusion, etc.;
  • Long-term use of immunosuppressants after organ transplantation;
  • Patients with a history of other malignant tumors before enrollment.

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

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: Intensity-modulated Radiotherapy Combined With Lobaplatin-based Concurrent Chemotherapy in the Treatment of Elderly Patients With Nasopharyngeal Carcinoma

This prospective, multicenter, single-arm, open-label phase II clinical study aimed to investigate the efficacy and safety of intensity-modulated radiotherapy combined with lobaplatin-based concurrent chemotherapy in the treatment of elderly patients with nasopharyngeal carcinoma

Read the detailed description

Lobaplatin, as a third-generation platinum-based chemotherapeutic agent, demonstrates equivalent therapeutic efficacy to cisplatin but significantly lower toxicity. Preliminary clinical trials have confirmed that lobaplatin shows substantial effectiveness in treating various cancers including breast cancer, esophageal cancer, colorectal cancer, and cervical cancer. Importantly, lobaplatin does not exhibit cross-resistance with cisplatin or carboplatin, indicating a promising application prospect.

Currently, lobaplatin has demonstrated clear efficacy in non-elderly nasopharyngeal carcinoma (NPC) chemotherapy. Guo Xiang et al. have confirmed that for non-elderly NPC patients, induction chemotherapy with lobaplatin followed by concurrent chemoradiotherapy may be a treatment option for locally advanced NPC. However, there is very limited research reporting on the use of lobaplatin in elderly NPC patients.

Based on the above theoretical considerations and our research results, lobaplatin shows good safety and reliable efficacy in treating elderly NPC, with minimal gastrointestinal reactions and low incidence of renal, neurotoxic, and ototoxic effects. This approach significantly enhances the quality of life for locally advanced elderly NPC patients. Therefore, the efficacy and safety of lobaplatin in concurrent chemotherapy for elderly NPC deserve further investigation. This study aims to evaluate the recent efficacy, safety, and toxic side effects of lobaplatin combined with intensity-modulated radiotherapy in the treatment of elderly NPC. Designed as a multicenter, open-label, prospective study, it aims to verify whether lobaplatin is an effective concurrent chemotherapeutic agent for elderly NPC, while further improving the quality of life for these patients under guarantees of therapeutic efficacy.

Being tested
IMRT combined with lobaplatin-based concurrent chemotherapy
Medical subject headings
Nasopharyngeal Neoplasms

What participants receive

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

  • IMRT combined with lobaplatin-based concurrent chemotherapyDrug

    IMRT combined with two cycles of lobaplatin-based concurrent chemotherapy

Study groups in NCT06688175
Study groupRoleWhat they receive
ExperimentalExperimentalin the treatment of elderly patients with nasopharyngeal carcinoma
Receives: Drug: IMRT combined with lobaplatin-based concurrent chemotherapy

What is being measured

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

  1. objective response rate (ORR)

    ORR encompasses both CR and PR.

    Measured: 6 months

Secondary outcomes (5)

  1. Safety

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 3 months

  2. Overall survival (OS)

    OS was defined as the time of NPC diagnosis until death from any cause.

    Measured: 3 years

  3. Locoregional relapse-free survival (LRFS)

    LRFS was measured as the duration time from the diagnosis of nasopharyngeal carcinoma to the occurrence of relapse in the nasopharynx or neck lymph nodes or until the last follow-up.

    Measured: 3 years

  4. Distant metastasis-free survival (DMFS)

    DMFS was defined as the duration time of nasopharyngeal carcinoma diagnosis to the time of distant metastasis or the last follow-up.

    Measured: 3 years

  5. Progression-free survival (PFS)

    PFS was referred to as the time from nasopharyngeal carcinoma diagnosis to the date of disease progression.

    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 posted14 Nov 2024
  2. Study start13 Nov 2024
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (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
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06688175
Sponsor's protocol ID
2022-KY062
Status last verified
Aug 2025
First submitted
12 Nov 2024
Last updated
7 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IMRT combined with lobaplatin-based concurrent chemotherapy in people with Nasopharyngeal Neoplasms and Elderly, run by The First Affiliated Hospital of Xiamen 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 10 inclusion and 10 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: enrolling by invitation, as of the sponsor's last update on 7 Aug 2025. 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 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?

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

objective response rate (ORR) (time frame: 6 months). 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 NCT06688175.

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 7 Aug 2025.

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