BridgeMD
New treatment option for Rectal Cancer
Official title A Pilot Study Evaluating β-hydroxybutyrate Supplementation Concomitant to Short-Course Radiotherapy Followed by Immunotherapy Combined With CAPEOX Neoadjuvant Therapy in Patients With Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT07239466
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, being studied as a potential treatment for rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a prospective phase II clinical trial aimed at exploring the potential benefits of supplementing β-hydroxybutyrate with existing short course radiotherapy sequential immunotherapy and CAPEOX therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma;
- inferior margin ≤ 10 cm from the anal verge;
- ECOG performance status score is 0-1;
You likely can't join if
- Patients with non-pMMR LARC；
- people who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists...
- Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in...
See the full eligibility criteria
- Patients or their family members agree to participate in the study and sign the informed consent form;
- Age 18-75 years, male or female;
- Histologically confirmed Locally Advanced rectal adenocarcinoma;
- inferior margin ≤ 10 cm from the anal verge;
- ECOG performance status score is 0-1;
- Untreated with anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, surgery, etc;
- There was no operative contraindication;
- Laboratory tests were required to meet the following requirements: white blood cell (WBC) ≥ 4×109/L; Absolute neutrophil count (ANC) ≥ 1.5×109/L; Platelet count ≥ 100×109/L; Hemoglobin ≥90 g/L; Serum total bilirubin ≤...
- Urinary protein \< 2+ or 24-hour urinary protein excretion \< 1 g at baseline.
- Patients with non-pMMR LARC；
- people who have previously received any form of immunotherapy, including but not limited to immune checkpoint inhibitors, immune checkpoint agonists, immune cell therapy, or any other treatment targeting tumor...
- Presence of any concurrent disease, condition (including laboratory abnormality), history of substance abuse, or current evidence thereof, which, in the judgment of the Investigator, may compromise subject safety...
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.