Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNA-level-relapse and Clinical-relapse Glioblastoma
Status:
Recruiting
Trial end date:
2023-12-01
Target enrollment:
Participant gender:
Summary
This is an ongoing Phase 2, open-label, single-center, non-randomized study of sintilimab
(one anti-PD-1 antibody same as nivolumab approved in China) plus bevacizumab administered in
a low dosage schedule in adult (≥ 18 years) participants with a clinical relapse or
circulating tumor DNA (ctDNA)-level relapse of glioblastoma (GBM).
This study has two non-comparative study groups. Both cohorts will receive the same study
drug sintilimab 200mg and bevacizumab 3mg/kg every 3 weeks. A stringent two-step
non-randomized process will be used to assign participants to one of the study groups.
Neither participants nor doctors but the researcher can choose which group participants are
in. No one knows if one study group is better or worse than the other. 60 total participants
are expected to participate in this study (30 participants in each cohort).
Grouping process: After enrollment, under the standard of care, participants will receive
regular tumor in situ fluid (fluid within the surgical cavity, TISF) sampling for ctDNA
analysis and recceive regular MRI. The researcher will study the TISF ctDNA and imaging
dynamics to determine whether the tumor reaches to ctDNA-level (Cohort 1) or clinical relapse
(Cohort 2). At the first step, all timely identified as ctDNA-level relapse tumors will be
assigned into the Cohort 1 and receive the study drug immediately, those failed to be timely
identified will be assigned into the Cohort 2 and receive the study drug after the clinical
relapse. At the second step, once either group reaches the target number, the new
participants will be all assigned into the other Cohort.