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Concurrent and Adjuvant PD1 Treatment Combined With Chemo-radiotherapy for High-risk Nasopharyngeal Carcinoma

ConditionsNasopharyngeal CancerChemotherapyRadiotherapyPD-1 Therapy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University

About this trial

Through multicenter, open-label, randomised clinical trials, we intend to demonstrate that concurrent and adjuvant PD-1 treatment added to chemo-radiotherapy could further decrease the rate of disease progression and improve the survival outcome of high risk patients with nasopharyngeal carcinoma compared with those treated with chemo-radiotherapy alone.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated type, i.e., WHO type II or type III).

Staged as T4N0-2M0,T1-4N3M0 (stage IVa) at diagnosis (according to the 8th AJCC edition).

Staged as T1-3N1-2M0, T2-3N0M0 (stage II-III) with SD/PD according to RECIST criteria or EBV DNA of >0 copies/mL after 3 cycles of GP induction chemotherapy.

Aged between 18-70 years.

Disqualifiers

Histologically confirmed keratinized squamous cell carcinoma (WHO type I) or basal squamous cell carcinoma.

Recurrent or metastatic nasopharyngeal carcinoma.

Staged as II-III which is evaluated as PR or CR and EBV DNA of 0 copies/mL after 3 cycles of GP induction chemotherapy.

Has known allergy to large molecule protein products or any compound of study therapy.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Camrelizumab plus chemo-radiotherapy

    Drug

    1. Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy. 2. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 3. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 4. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

  • Chemo-radiotherapy alone

    Drug

    1. Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks. 2. Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks. 3. IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy

Treatment groups

388 Participants
are divided into 2 treatment groups
Group A: Camrelizumab plus chemo-radiotherapy armExperimental treatment 1 intervention
Group B: Chemo-radiotherapy armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Progress-free survival (PFS)

Defined as time from randomization to locoregional or distant metastasis relapse or death from any cause, whichever occurred first.

Time frame
3 years

Secondary outcomes

1

Overall Survival (OS)

Defined as the time interval from randomization to death due to any cause.

Time frame
3 years
2

Distant Metastasis-Free Survival (DMFS)

Defined as the time interval from randomisation to the date of first distant metastases.

Time frame
3 years
3

Locoregional Relapse-Free Survival (LRRFS)

Defined as the time from randomisation to the date of first locoregional relapse.

Time frame
3 years
4

Incidence of treatment related acute complications

The proportion of patients with treatment related acute complications according to NCI-CTC5.0 criteria and RTOG criteria.

Time frame
up to 1 years

Other outcomes

Sponsors and contacts

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

Sun Yat-sen University

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Collaborator

Zhongshan People's Hospital, Guangdong, China

Collaborator

Yuebei People's Hospital

Collaborator

Wuzhou Red Cross Hospital

Collaborator

Fifth Affiliated Hospital, Sun Yat-Sen University

Collaborator

Source ClinicalTrials.gov
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