Low-dose Radiotherapy and Chemoimmunotherapy in Nasopharyngeal Carcinoma With Liver Metastasis

Plain English Summary

LDRT and Chemoimmunotherapy in NPC With Liver Metastasis is a Phase 2 clinical trial sponsored by Hunan Cancer Hospital studying Nasopharyngeal Cancinoma (NPC). This trial tests a combination of low-dose radiation, chemotherapy, and immunotherapy. It is for adults with nasopharyngeal cancer that has spread to the liver. Participants will receive the combination treatment; alternatives include standard chemotherapy or other targeted therapies. The study is looking for 26 participants and is currently recruiting. The trial aims to enroll 26 participants.

Official Summary

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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Adults aged 18-70 with a confirmed diagnosis of nasopharyngeal cancer that has spread to the liver. Patients must have at least one measurable tumor in the liver and good general health. Individuals who have had certain previous treatments for cancer, have active autoimmune diseases, or certain other serious health conditions may not be eligible. This trial is studying Nasopharyngeal Cancinoma (NPC), so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary goal is to see how long patients live without their liver cancer worsening, measured one year after starting treatment. The specific primary outcome measures are: Intrahepatic progression-free survival (iPFS) (1 year). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a critical need for better treatments for nasopharyngeal cancer that has spread to the liver, a challenging stage of the disease. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Nasopharyngeal Cancinoma (NPC), where improved treatment options are needed.

Investor Insight

This Phase 2 trial targets a specific cancer with limited treatment options, suggesting a potential for a novel therapy if successful, which could attract further investment for later-stage developmen Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor about the specific drugs used, potential side effects, and how often you'll need to visit the clinic. Participation involves receiving radiation, chemotherapy, and immunotherapy over a period of time, with regular check-ups and tests. Be prepared for potential side effects and discuss any concerns with your healthcare team promptly. This trial is currently recruiting participants. The trial is being conducted at 7 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 26 participants

Interventions

• OTHER: Low-dose radiotherapy combine with chemoimmunotherapy — 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)

Primary Outcomes

• Intrahepatic progression-free survival (iPFS) (1 year)

Secondary Outcomes

• Progression-free survival (PFS) (1 year)
• Overall survival (OS) (2 year)
• Objective response rate (ORR) (18 weeks)
• Incidence rate of adverse events (AEs) (2 year)

Full Eligibility Criteria

Inclusion Criteria:

1. Age ≥ 18 years and ≤ 70 years, male or non-pregnant female.
2. Histologically confirmed with nonkeratinizing carcinoma of the nasopharynx (differentiated or undifferentiated type, WHO II or III)
3. Stage IVB (AJCC 8th edition staging)
4. 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.
5. ECOG performance status: 0 or 1
6. Must have at least one measurable lesion (assessed according to RECIST v1.1)
7. Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L; platelets ≥ 100 × 10\^9/L; hemoglobin ≥ 90 g/L.
8. International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × upper limit of normal (ULN); activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN
9. Serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min.
10. Serum total bilirubin ≤ 1.5 × ULN (patients with Gilbert's syndrome may be included if total bilirubin \< 3 × ULN); AST and ALT ≤ 5 × ULN （because of liver metastasis）

Exclusion Criteria:

1. Patients with tumor recurrence at the primary site who have previously received radical radiotherapy.
2. Tumor invasion involving major blood vessels, with a high risk of significant bleeding as assessed by the investigator.
3. Systemic anticancer therapy, including hormone therapy, administered within 28 days prior to the initiation of the study treatment.
4. Previous treatment with immune checkpoint inhibitors (e.g., PD-1/PD-L1, CTLA-4).
5. Patients with active autoimmune diseases or a history of autoimmune diseases with a risk of recurrence.
6. Known history of other malignancies (except cured basal cell carcinoma or carcinoma in situ of the cervix).
7. Conditions requiring systemic corticosteroid therapy (equivalent to \>10 mg/day of prednisone or similar medications) or other immunosuppressive therapy within ≤14 days prior to treatment.
8. Uncontrolled diabetes or laboratory abnormalities ≥Grade 1 in potassium, sodium, or corrected calcium levels despite standard treatment, or ≥Grade 3 hypoalbuminemia within ≤14 days before treatment.
9. History of the following diseases: interstitial lung disease, non-infectious pneumonitis, or uncontrolled diseases, including pulmonary fibrosis or acute lung disease.
10. Severe chronic or active infections requiring systemic antibiotics, antifungals, or antivirals within ≤14 days before the first dose of the investigational drug (including tuberculosis infection).
11. Known history of HIV infection.
12. Untreated chronic hepatitis B patients or hepatitis B virus (HBV) carriers with HBV DNA ≥500 IU/mL, or active hepatitis C virus (HCV) carriers.
13. Any major surgery requiring general anesthesia within ≤28 days prior to treatment.
14. Previous allogeneic stem cell transplantation or organ transplantation.
15. Any cardiovascular risk factors, including: cardiac chest pain that restricts daily instrumental activities ≤28 days before treatment. Symptomatic pulmonary embolism within ≤3 months before treatment. Acute myocardial infarction within ≤6 months before treatment. History of heart failure meeting New York Heart Association (NYHA) Class III or IV within ≤6 months before treatment. Grade ≥2 ventricular arrhythmias within ≤6 months before treatment. History of cerebrovascular accident within ≤6 months before the first dose of the investigational drug.
16. Evident bleeding tendencies or clinically significant bleeding symptoms ≤28 days prior to randomization, including but not limited to gastrointestinal bleeding, nasal bleeding (excluding epistaxis or retrograde blood-stained nasal discharge), and persistent bleeding disorders or coagulopathy.
17. Known allergy to any component of the investigational drug or a history of severe hypersensitivity to other monoclonal antibodies.
18. Peripheral neuropathy of Grade ≥2 as defined by NCI CTCAE v5.0.
19. Administration of live vaccines within ≤4 weeks prior to treatment.
20. Underlying medical conditions (including laboratory abnormalities) or alcohol/drug abuse or dependency that could impair drug administration, interpretation of drug toxicity, or adverse events (AEs), or could compromise study compliance or execution.
21. Pregnant or breastfeeding women.
22. Other factors deemed by the investigator that could lead to the premature termination of the study, such as other severe illnesses, significant laboratory abnormalities, or family/social factors that could affect participant safety or the collection of study data.

Trial Locations

• Third Xiangya Hospital, Central South University,, Changsha, Hunan, China
• Xiangya Hospital of Central South University, Changsha, Hunan, China
• Hunan Cancer Hospital, Changsha, Hunan, China
• Hunan Cancer Hospital, Changsha, Hunan, China
• The First People's Hospital of Chenzhou, Chenzhou, Hunan, China
• The Central Hospital of Shaoyang, Shaoyang, Hunan, China
• Yueyang Central Hospital, Yueyang, Hunan, China

Frequently Asked Questions

Related Conditions

• Nasopharyngeal Carcinoma (NPC)
• Metastatic Cancer
• Liver Metastasis
• Head and Neck Cancers
• Oncology
• Radiation Therapy
• Chemotherapy
• Immunotherapy
• Cancer Treatment
• Clinical Trials

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