Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNA-level-relapse and Clinical-relapse Glioblastoma

Sponsor
Henan Provincial People's Hospital
Study ID
NCT05502991
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Aug 16, 2022
Start date
Dec 11, 2022
Status verified
Aug 2022
Primary completion
Dec 31, 2025
Completion
Dec 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Subjects with ctDNA-level-relapse glioblastoma before clinical relapse, determined according to the dynamics of TISF ctDNA.
  • Experimental: Cohort 2
    Subjects with clinical-relapse glioblastoma, determined according to the response assessment in neuro-oncology (RANO) criteria for gliomas.

Primary Outcome Measure

Overall survival rate at 12 months (Cohort 2) [ Time Frame: Up to 12 months after beginning therapy ]

Central Contacts

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