Actively Recruiting
Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma
Led by Henan Provincial People's Hospital · Updated on 2022-09-27
80
Participants Needed
1
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 Oligodendroglioma(WHO III). This study has three non-comparative study groups. Cohort 1 and Cohort 2 will receive the same study drug sintilimab 200mg and bevacizumab 3mg/kg every 3 weeks. Cohort 3 will take only standard treatment. A stringent three-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. 80 total participants are expected to participate in this study (30 participants in Cohort 1 and Cohort 2). 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 Cohort 1 or Cohort 2 reaches the target number, the new participants will be all assigned into the other Cohort. In the third step, if no CTDNA-level or clinical relapse was observed within 60 months after surgery, patients were assigned to Cohort 3 and further analyzed for prognostic biomarkers compared with Cohort 1 and Cohort 2.
CONDITIONS
Official Title
Sintilimab (One Anti-PD-1 Antibody) Plus Low-dose Bevacizumab for ctDNAlevel- Relapse and Clinical-relapse Oligodendroglioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and HIPAA authorization obtained before any study procedures
- Willingness and ability to follow scheduled visits, treatments, lab tests, MRI scans, and tumor fluid collection
- Histological confirmation of oligodendroglioma (WHO grade III)
- Tumor resection surgery performed at Henan Provincial People's Hospital with reservoir implanted for tumor fluid collection
- At least 28 days since surgery with full recovery and no ongoing safety issues
- Karnofsky performance status of 70 or higher
- Life expectancy greater than 12 weeks
You will not qualify if you...
- More than two recurrences of oligodendroglioma
- Presence of extracranial metastases, significant leptomeningeal disease, or tumors mainly in brainstem or spinal cord
- Serious or uncontrolled medical conditions increasing risk or affecting study participation
- Active or suspected autoimmune disease requiring systemic immunosuppressive treatment within 14 days
- Prior radiation therapy other than standard focal radiation as first-line treatment
- Previous treatment with carmustine wafer except as first-line and at least 6 months before enrollment
- Previous treatment with bevacizumab, other VEGF or anti-angiogenic agents
- Prior therapy with PD-1, PD-L1, or CTLA-4 targeted drugs
- Evidence of more than Grade 1 CNS hemorrhage on baseline MRI
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg) within 7 days before first treatment
- History of hypertensive crisis, hypertensive encephalopathy, or reversible posterior leukoencephalopathy syndrome
- History of gastrointestinal diverticulitis, perforation, or abscess
- Active significant cardiovascular disease including recent stroke or heart attack, unstable angina, or serious arrhythmia
- Significant vascular disease or recent venous thromboembolism within 3-6 months prior to treatment
- Recent history of pulmonary hemorrhage or hemoptysis grade 2 or higher
- History or evidence of inherited bleeding disorders or significant coagulopathy
- Use of anticoagulants within 10 days before study if posing significant bleeding risk
- Major surgery or traumatic injury within 28 days prior to first treatment or expected during study
- Minor surgery within 7 days (stereotactic biopsy) or 2 days (vascular access device) of first treatment
- History of intracranial abscess within 6 months prior to enrollment
- History of active gastrointestinal bleeding within 6 months prior to enrollment
- Serious non-healing wounds, active ulcers, or untreated fractures
- Unable or unwilling to have head contrast-enhanced MRI
- Positive hepatitis B surface antigen or detectable hepatitis C RNA indicating infection
- Known HIV infection or AIDS
- History of severe allergic reaction to monoclonal antibodies
- Need for steroids greater than 4 mg/day dexamethasone or equivalent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
Research Team
X
Xingyao Bu, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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