BridgeMD
New treatment option for Rectal Cancer
Official title Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT06718543
What this study is testing
What is AK112 with SCRT and CapeOX?
AK112 with SCRT and CapeOX is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for rectal cancer.
Also referred to as short-course radiotherapy, CapeOX.
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 phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
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 80
You may be able to join if
- Signed written informed consent.
- Age 18-80 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
- Able to swallow tablets.
You likely can't join if
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments. 4.Active autoimmune diseases or history of significant...
See the full eligibility criteria
- Signed written informed consent.
- Age 18-80 years, male or female.
- Histologically confirmed rectal adenocarcinoma.
- Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
- Able to swallow tablets.
- ECOG Performance Status of 0-1.
- No prior treatment for rectal cancer, including surgery, radiotherapy, 8.chemotherapy, immunotherapy, or targeted therapy. 9.Fit for surgery with no contraindications. 10.Normal organ function. 11.Tumor ≤12 cm from the...
- Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
- Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments. 4.Active autoimmune diseases or history of significant autoimmune conditions. 5.Immunodeficiency disorders or history of organ/bone...
The study team makes the final eligibility decision.
Where it's taking place
- Chongqing, Chongqing Municipality, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chongqing, Chongqing Municipality, 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.