BridgeMD
New treatment option for Rectal Cancer
Official title Node-Sparing Short-Course Radiation Combined With Capecitabine and PD-1/CTLA-4 for MSS Early Rectal Cancer
ClinicalTrials.gov ID: NCT07068763
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, given as an once-daily pill taken by mouth, 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 is a single-arm, prospective, multicenter study evaluating a novel neoadjuvant treatment strategy for patients with early, mid-low rectal adenocarcinoma that is microsatellite stable (MSS). Instead of irradiating regional lymph nodes, we deliver short-course radiotherapy (25 Gy in 5 fractions) exclusively to the primary tumor ("lymph-node-sparing" approach), immediately followed by four 3-week cycles of capecitabine plus combined PD-1/CTLA-4 immune checkpoint inhibitors.
- 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 80
You may be able to join if
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-80.
- Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the...
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is...
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
You likely can't join if
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with metastatic regional or non-regional lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
See the full eligibility criteria
- Patients who have a strong willingness to preserve the anus and are willing to receive neoadjuvant therapy.
- Male or Female aged 18-80.
- Patients diagnosed with low rectal cancer within 7 cm from the lower edge of the tumor to the anal verge by pelvic MRI and rectal ultrasound, the clinical stage is cT2-3N0M0.
- Histologically confirmed rectal adenocarcinoma; Genetic testing suggests MSI-L or MSS, or tumor biopsy immunohistochemistry reveals pMMR, that is, MSH1, MSH2, MSH6, and PMS2 are all positive.
- Eastern Cooperative Oncology Group (ECOG) score 0-1.
- No previous treatment (including anti-tumor therapy, immunotherapy or pelvic radiation).
- Informed consent form signed.
- Patients with a previous history of malignant tumors besides rectal cancer.
- Patients with distant metastases before enrollment.
- Patients with metastatic regional or non-regional lymph nodes are assessed by MRI or CT.
- Patients with obstruction, perforation, or bleeding that require emergency surgery.
- Patients with severe concomitant diseases and estimated survival time ≤ 5 years.
- Allergic to any component of the therapy.
- Patients who received immunosuppressive or systemic hormone therapy for immunosuppressive purposes within 1 month prior to the initiation of therapy.
- Contraindications to radiotherapy and chemotherapy.
- Patients who have received any other experimental drug (including immunotherapy) or participated in another treatment clinical trial within 30 days before screening.
- Factors leading to study termination, such as alcoholism, drug abuse, other serious illnesses (including psychiatric disorders) requiring combination therapy, and patients with severe laboratory abnormalities. Patients...
- Vulnerable groups, including mentally ill, cognitively impaired, critically ill patients, minors, pregnant or lactating women, illiterate, etc. Other conditions that investigators consider not suitable for this study.
- Patient not suitable for participating by other concerns of researchers.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, 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 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, 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.