Adding PD-1 Inhibitor to Neoadjuvant and Adjuvant for NPC

Jiangxi Provincial Cancer Hospital

Status and phase: Enrolling; Phase 3

Conditions: Nasopharyngeal Carcinoma

Treatments: Drug: PD-1 antibody; Radiation: IMRT; Drug: Gemcitabine; Drug: Cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT04557020

NPC2020-001

Details and patient eligibility

About

This is a randomized clinical trial comparing neoadjuvant and adjuvant PD-1 inhibitor Toripalimab plus neoadjuvant chemotherapy and concurrent chemoradiotherapy versus neoadjuvant chemotherapy and concurrent chemoradiotherapy alone in high-risk nasopharyngeal carcinoma

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma
2. Clinical staged as T4 or N3 （according to the 8th AJCC edition）
3. No evidence of distant metastasis (M0)
4. Male and no pregnant female
5. ECOG (Eastern Cooperative OncologyGroup) scale 0-1
6. WBC ≥ 4×109 /L and PLT ≥4×109 /L and HGB ≥90 g/L
7. Normal liver function test (ALT、AST ≤ 2.5×ULN, TBIL≤ 2.0×ULN)
8. Normal renal function test ( creatinine clearance ≥60 ml/min)

Exclusion criteria

1. Recurrent or distant metastatic disease.
2. History of malignant tumors (except cured basal cell carcinoma or uterine cervical carcinoma in situ) within the last 5 years.
3. History of radiotherapy or chemotherapy.
4. History of immunodeficiency disease
5. History of organ transplantation
6. Presence of life-threatening illness
7. Uncontrolled hypercalcemia
8. Severe uncontrolled medical conditions or active infectious diseases
9. Use of large doses of glucocorticoids, anti-cancer monoclonal antibodies, or other immunosuppressive agents within 4 weeks.
10. Pregnant or breastfeeding female
11. Emotional disturbance or mental illness
12. Refusal or inability to sign informed consent

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Arm A

Experimental group

Description:

IC with anti-PD1 mab+CCRT+anti-PD1 mab

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Drug: PD-1 antibody

Radiation: IMRT

Arm B

Active Comparator group

Description:

IC+CCRT

Treatment:

Drug: Cisplatin

Drug: Gemcitabine

Radiation: IMRT