GNT Induction Treatment in Locally Advanced NPC

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Gemcitabine Combined With Nimotuzumab and Toripalimab as Induction Treatment Followed by Chemoradiotherapy for Locally Advanced Nasopharyngeal carcinoma-a Multicenter, Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06026878
• Other study ID #: AFMMUChina
• Status: Recruiting
• Phase: Phase 3
• Start date: September 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: September 2023
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare overall response rate between gemcitabine, nimotuzumab and toripalimab as induction treatment and gemcitabine combined with cisplatine in paitents with locally advanced nasopharyngeal carcinoma. It aims to answer whether gemcitabine, nimotuzumab and toripalimab as induction treatment show non-inferiority compared to GP induction chemotherapy. Participants will be randomly divided into two induction treatment groups.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 228
• Est. completion date: September 30, 2027
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age 18 to 75 years old.

2. Pathologically or cytologically confirmed stage III-IVB nasopharyngeal keratinizing squamous cell carcinoma or non-keratinizing squamous cell carcinoma.

3. Patients suitable for radical radiochemotherapy.

4. ECOG PS score of 0-1.

5. According to the RECIST 1.1 criteria, there is at least one measurable lesion. Basic hematological parameters are normal: white blood cell count =4×10^9/L; absolute neutrophil count =1.5×10^9/L; platelets =100×10^9/L; hemoglobin =90 g/L.

6. Basically normal renal function: serum creatinine =1.5×ULN or creatinine clearance rate (CrCl) > 60 mL/min (using the Cockcroft-Gault formula): For females: CrCl = (140-age) x weight (kg) x 0.85 / (72 x Scr mg/dl) For males: CrCl = (140-age) x weight (kg) x 1.00 / (72 x Scr mg/dl)

7. Basically normal liver function: serum total bilirubin =1.5×ULN; aspartate aminotransferase (AST) =2.5×ULN; alanine aminotransferase (ALT) =2.5×ULN.

8. Signed written informed consent.

Exclusion Criteria:

1. Patients who have previously undergone immunotherapy or targeted therapy.

2. Participated in any other interventional clinical trials within 30 days before screening.

3. History of other malignancies (except for cured skin basal cell carcinoma).

4. History of primary immunodeficiency.

5. Presence of uncontrolled concurrent diseases (such as heart failure, severe lung disease, severe liver disease, mental disease, etc.).

6. Known HIV infection, active viral hepatitis, or tuberculosis.

7. Major surgery within 90 days before the first dose of the study drug, or planned surgery.

8. Allergic to the drugs used in this protocol or their components.

9. Pregnant (confirmed by blood or urine HCG tests) or breastfeeding women, or those of childbearing age unwilling or unable to take effective contraceptive measures (applicable to both male and female subjects) until at least 6 months after the last trial treatment.

10. The investigator believes the subject is not suitable for this study.

11. Unwilling to participate in this study or unable to sign the informed consent form.

12. Live vaccinations within 30 days of dosing.

Related Conditions & MeSH terms

• Carcinoma
• Nasopharyngeal Carcinoma

Intervention

Drug:
• gemcitabine,nimotuzumab, toripalimab
same as before
• gemcitabine, cisplatin
same as before

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse events	treatment-related adverse events during treatment and follow-up time	through study completion, an average of 1 year
Primary	overall response rate	the proportion of patients who achieve complete response and partial response after induction therapy	three weeks after induction therapy
Secondary	2-year overall survival	2-year survival rate of patients enrolled in this study	From date of randomization until the date of death from any cause, whichever came first, assessed up to 100 months
Secondary	2-year distant metastasis-free survival	2-year distant metastasis-free survival rate of patients enrolled in this study	From date of randomization until the date of distant metastasis or last follow-up time,, whichever came first, assessed up to 100 months
Secondary	2-year local regional recurrence-free survival	2-year local regional recurrence-free survival rate of patients enrolled in this study	From date of randomization until the date of local and/or lymph node recurrence or last follow-up time,, whichever came first, assessed up to 100 months