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LDRT and Chemoimmunotherapy in NPC With Liver Metastasis

ConditionNasopharyngeal Cancinoma (NPC)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHunan Cancer Hospital

About this trial

This study aims to evaluate the efficacy and toxicity of adding low-dose radiotherapy to chemoimmunotherapy as a first-line treatment for nasopharyngeal carcinoma patients with liver metastasis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.

Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)

Stage IVB (AJCC 8th edition staging)

De novo nasopharyngeal carcinoma with liver metastasis, or patients who had received curative treatment (radical radiotherapy or radical radiotherapy combined with chemotherapy) and developed liver metastasis more than 6 months after treatment completion.

Disqualifiers

Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.

Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.

Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.

Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4).

Trial design

Design model

Single group

Treatments tested in this trial

  • Low-dose radiotherapy combine with chemoimmunotherapy

    Other intervention

    Radiation: 1.4Gy for 5 days to the liver metastasis before chemoimmunotherapy. Chemoimmunotherapy: gemcitabine(1000mg per square meter on days 1,8) , cisplatin (80mg per square meter on day 1), penpulimab (200mg, day1)

Treatment groups

26 Participants
are divided into 1 treatment group
Group A: LDRT and chemoimmunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Intrahepatic progression-free survival (iPFS)

Defined as the time from the start of therapy to the first progression in liver

Time frame
1 year

Secondary outcomes

1

Progression-free survival (PFS)

Defined as the time from the start of therapy to documented local or regional relapse, distant metastasis, or death from any cause, whichever occurred first.

Time frame
1 year
2

Overall survival (OS)

Defined as the time from the start of therapy to death from any cause or censored at the date of last follow-up.

Time frame
2 year
3

Objective response rate (ORR)

Defined as the proportion of patients achieving complete response (CR) or partial response (PR) in all patients. According to RECIST 1.1 evaluation criteria, physicians use the efficacy evaluation record as the determination criteria

Time frame
18 weeks
4

Incidence rate of adverse events (AEs)

Analysis of acute and late adverse events (AEs) are evaluated by CTCAE v5.0.

Time frame
2 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hunan Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov
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