Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-ad… (NCT06752382) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Sintilimab Combined With Bevacizumab and TP Chemotherapy in the Treatment of High Risk Locally-advanced NPC
China58 participantsStarted 2024-12-31
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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).
✓. ECOG score 0-1.
✓. Adequate bone marrow/liver and kidney function/heart and lung and other physiological function reserves, expected to successfully complete chemoradiotherapy and immunotherapy.
Exclusion criteria
✕. 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.
What they're measuring
1
radiographic complete response rate
Timeframe: At the end of Cycle 3 (each cycle is 21 days)
✕. 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.
✕. History of immunodeficiency; positive HIV antibody test; current chronic use of systemic corticosteroids or other immunosuppressive agents; local, ocular, intra-articular, intranasal, and inhaled corticosteroids are allowed.
✕. Patients who are pregnant or nursing (for women of childbearing age, pregnancy testing should be considered and the use of effective contraception during treatment should be emphasized).
✕. Subjects with known active pulmonary tuberculosis (TB) and suspected active TB require clinical examination to rule out; known active syphilis infection.
✕. known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 9. history of pneumonitis/interstitial lung disease requiring systemic corticosteroids or current pneumonitis.