Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-advanced NPC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
Nearly half of the world's nasopharyngeal cancer occurs in China, among which the highest incidence in Guangdong and Guangxi, so the nickname "Guangdong tumor". Due to the hidden position of the nasopharynx, 70% to 80% of patients are found in the middle and late stages. Immunotherapy plays a significant role in nasopharyngeal carcinoma. Professor Ma Jun of Sun Yat-sen University reported a phase 3 clinical study at ASCO meeting in 2023, which compared the efficacy of Sintilimab combined with GP chemotherapy versus GP chemotherapy alone in locally advanced nasopharyngeal carcinoma, and the results showed that EFS in the immune group decreased by 41% in 3 years. The risk of local recurrence-free survival and distant metastasis was reduced by 48% and 43%, respectively. However, a subgroup analysis of the study found that low-risk patients benefited more, while N2-N3 patients benefited only HR There is 0.78, new treatment options need to be explored in clinic. Therefore, the investigators plan to initiate a prospective study to evaluate the efficacy and safety of Sintilimab Combined With Bevacizumab and TP Chemotherapy for high-risk locally advanced nasopharyngeal carcinoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Signed a written informed consent form (ICF) voluntarily.
Male or female, aged from 18 to 75 years.
Histologically newly diagnosed patients with differentiated or undifferentiated non-keratinous carcinoma (according to World Health Organization [WHO] histological types).
Patients with tumor stage TanyN2-3M0 (according to AJCC Edition 8).
Disqualifiers
subjects with pathologically diagnosed adenocarcinoma or sarcoma of the nasopharynx.
subject has other malignancy within 3 years prior to first dose except nasopharyngeal carcinoma. Subjects with other malignancies that have been cured by local therapy, such as basal or cutaneous squamous cell carcinoma, superficial bladder cancer, cervical or breast carcinoma in situ, are excluded.
Participated in treatment with an investigational drug or used an investigational device within 4 weeks prior to the first dose.
active or previous definite inflammatory bowel disease (e.g., Crohn 's disease or ulcerative colitis) disease.
Trial design
Design model
Single group
Treatments tested in this trial
Experimental drug
DrugInduction therapy was sintilimab 200mg IV d1, bevacizumab 7.5mg/kg IV d1, albumin-bound paclitaxel 260mg/m2 IV d1 and cisplatin 80mg/m2 IV d1, once every 3 weeks, a total of 3 cycles.
Treatment groups
58 Participants
are divided into 1 treatment groupGroup A: experimentalExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
radiographic complete response rate
CR rate was evaluated according to recist 1.1 criteria
Time frame
At the end of Cycle 3 (each cycle is 21 days)Secondary outcomes
1
progression-free survival
The time from the time the patient receives treatment to the time the disease progresses or death (whatever the cause)
Time frame
2 years2
AE
The incidence and severity of acute effects were evaluated according to the NCI CTCAE (version 5.0) classification of the severity of adverse events, and the correlation with the study drugs was analyzed. Safety and tolerability of changes in vital signs, physical examination, and laboratory tests during the study were evaluated according to the severity of adverse events (AE) according to NCI CTCAE (version 5.0).
Time frame
2 yearsSponsors and contacts
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Source ClinicalTrials.gov
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