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Tests treatment safety and results for Locally Advanced Rectal Cancer (LARC)
Official title A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer
ClinicalTrials.gov ID: NCT07347951
What this study is testing
What is CAPOX chemotherapy?
CAPOX chemotherapy is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for locally advanced rectal cancer (larc).
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
- In a single-center, prospective, phase II study (ClinicalTrials registration number: [to be filled in]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant 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 who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.
- Aged between 18 and 75 years, with no gender restrictions.
- Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0/+M0, and lymph nodes...
- Histologically diagnosed with rectal adenocarcinoma; genetic testing indicates MSS or MSI-L, or immunohistochemistry of tumor biopsy indicates pMMR...
- ECOG performance status score of 0-1. ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion...
You likely can't join if
- In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.
- Patients with metastases to other sites indicated by preoperative staging.
- Patients with suspicious positive lymph nodes in non-draining areas of the rectum, such as the internal and external iliac lymph nodes, as assessed...
- Patients requiring emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal hemorrhage.
- Patients with severe comorbid conditions and an estimated life expectancy of ≤5 years.
- Patients with known allergies to any components in the study. ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for...
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, 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 Wenzhou, Zhejiang, 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.