THIO + Cadonilimab for Liver Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether cadonilimab (an immunotherapy drug), with or without ateganosine, can effectively and safely treat surgically removable liver cancer. Researchers aim to determine if these drugs can benefit individuals with hepatocellular carcinoma (HCC), a common type of liver cancer. This trial may suit those diagnosed with liver cancer that can be fully removed by surgery and who have not received certain cancer treatments before. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Do I need to stop my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, if you have Hepatitis B, you must be on anti-viral therapy before starting the trial. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous research has shown that cadonilimab has manageable side effects, indicating it is generally well-tolerated. Studies found that combining cadonilimab with other treatments did not result in severe side effects, and no serious treatment-related negative reactions were observed. This suggests cadonilimab is relatively safe, with non-severe side effects.
While specific information on ateganosine is limited, combining it with cadonilimab aims to enhance liver cancer treatment. As this trial is in its early phase, detailed safety information for ateganosine may still be developing. However, cadonilimab's use in various trials for different cancers provides some assurance of its safety.
Participants should consider these findings when deciding to join the trial, keeping in mind that early trials often focus on gathering more detailed safety information.12345Why are researchers excited about this trial's treatments?
Researchers are excited about Cadonilimab for liver cancer because it offers a unique approach compared to current treatments like sorafenib or lenvatinib, which primarily target blood vessel growth. Cadonilimab is a bispecific antibody that simultaneously targets two immune checkpoints, PD-1 and CTLA-4, helping to reinvigorate the immune system's fight against cancer cells. Additionally, the combination with Ateganocine in one of the study arms may further enhance its effectiveness by adding a different mechanism that disrupts cancer cell growth. This multi-faceted strategy could potentially lead to better outcomes for patients with liver cancer.
What evidence suggests that this trial's treatments could be effective for liver cancer?
This trial will evaluate the effectiveness of different treatment combinations for liver cancer. Studies suggest that cadonilimab, which participants in this trial may receive, shows promising results against liver cancer. Earlier research showed that patients treated with cadonilimab experienced positive effects, with tumors either shrinking or stopping growth. In this trial, some participants will receive cadonilimab alone, while others will receive it combined with ateganosine. Although less information exists about ateganosine, it is being tested with cadonilimab to determine if it can enhance the treatment's effectiveness. Overall, early findings are positive, but more research is needed to confirm these results.13567
Are You a Good Fit for This Trial?
This trial is for adults (18+) with liver cancer (HCC) that can be surgically removed. Participants must have good organ function, no prior treatment with certain immune drugs, and be healthy enough for surgery. People can't join if they have severe bleeding issues, major recent surgeries, active autoimmune diseases, or are pregnant/nursing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either cadonilimab alone, ateganosine alone, or a combination of ateganosine and cadonilimab over 3 cycles of 21 days each
Surgery Evaluation
Participants are evaluated for surgery after completing the treatment cycles
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of treatment-related delays and adverse events
Long-term Follow-up
Participants are monitored for survival outcomes and treatment-emergent adverse events
What Are the Treatments Tested in This Trial?
Interventions
- Cadonilimab
Trial Overview
The study compares the safety and effectiveness of cadonilimab alone versus cadonilimab combined with ateganosine in people with resectable liver cancer. Patients are assigned to different groups to see which approach works better before surgery.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes
Ateganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes
Ateganosine: 60 mg/day (180 mg/cycle) IV over 30 minutes±5 minutes Cadonilimab: 10 mg/kg IV over 60 minutes±5 minutes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Texas Southwestern Medical Center
Lead Sponsor
Maia Biotechnology
Industry Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
a phase Ib/II single-arm clinical trial
The efficacy and safety of cadonilimab combined with lenvatinib for first-line treatment of advanced hepatocellular carcinoma (COMPASSION-08): a ...
The efficacy and safety of cadonilimab combined with ... - PMC
In conclusion, cadonilimab combined with lenvatinib showed encouraging antitumor activity and manageable toxicity, which was a novel therapy and ...
Cadonilimab (PD-1/CTLA-4) in combination with lenvatinib in ...
This study demonstrated the efficacy and safety of this combination, potentially improving outcomes as a first-line therapy, and offering a ...
THIO + Cadonilimab for Liver Cancer · Info for Participants
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable ...
Akeso Announces Completion of Patient Enrollment in The ...
Cadonilimab is the world's first approved bispecific immunotherapy for cancer. Previous studies have shown its significant efficacy and ...
THIO and Cadonilimab in Resectable Hepatocellular ...
The goal of this clinical study is to find out if cadonilimab or ateganosine plus cadonilimab is effective and safe in treating resectable ...
Updated efficacy and safety data for cadonilimab plus ...
No grade 4-5 TRAEs were observed. The median progression-free survival (mPFS) was 8 months, and the median overall survival (mOS) was not ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.