Health TrialsbyHealthPanel

GEP Combined With Radiotherapy in Non-locally Treatable Recurrent NPC

ConditionNasopharynx Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang Cancer Hospital

About this trial

This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managing unresectable recurrent nasopharyngeal carcinoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged ≥18 years;

ECOG performance status 0-2;

Pathological or clinical imaging diagnosis of recurrent nasopharyngeal carcinoma;

With imaging assessable lesions (assessed by RECIST 1.1 criteria);

Disqualifiers

Subjects who cannot accept or tolerate chemotherapy or radiotherapy for various reasons;

Subjects who can be cured by definitive radiotherapy or surgery;

Subjects who have undergone major surgical procedures within the past 4 weeks or have not fully recovered from such procedures;

Subjects who are currently participating in other drug clinical trials;

Trial design

Design model

Single group

Treatments tested in this trial

  • GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy

    Drug

    The R-GEP regimen is as follows: Gemcitabine (G; 1.0 g/m2, d1, d8) in combination with recombinant human vascular endothelial growth factor (E; 150 mg, continuous intravenous infusion for 72 hours) and Carelizumab (P; 200 mg), administered every three weeks for a total of six cycles. During the 2nd-4th cycles, low-dose radiotherapy is administered to modulate the immune microenvironment (R: one course of radiotherapy per cycle: including booster fractions of 1 Gy\*3 times for the recurrent lesions, once a day, for three cycles). Approximately three weeks after the completion of the sixth cycle of GEP regimen (or the last cycle), high-dose fractionated radiotherapy (5-8 Gy\*5 times, once a day) is given to the recurrent lesions. Immune maintenance therapy continues until one year after treatment completion or disease progression.

Treatment groups

41 Participants
are divided into 1 treatment group
Group A: GEPExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

3 year OS rate

3 year OS rate

Time frame
3 year

Secondary outcomes

1

ORR

ORR

Time frame
3year
2

DCR

DCR

Time frame
3year
3

3 year PFS rate

3 year PFS rate

Time frame
3 year

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

Zhejiang Cancer Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: