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New treatment option for Locally Advanced Rectal Carcinoma
Official title Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer
ClinicalTrials.gov ID: NCT05601505
What this study is testing
- What it's testing
- Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study.
- 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 75
You may be able to join if
- Aged 18-75 years;
- ECOG score 0-2;
- Rectal adenocarcinoma confirmed by pathology;
- The lower margin of the tumor was less than 12cm from the anal margin;
- Patients with clinical stage cT3-4N0M0 or cTanyN+M0;
You likely can't join if
- ECOG score \> 2;
- Patients with multiple primary colorectal cancers;
- A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer...
- Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;
- pregnant or lactating women;
- Patients with a history of severe mental illness, immune disease, hormone medication;
See the full eligibility criteria
- Aged 18-75 years;
- ECOG score 0-2;
- Rectal adenocarcinoma confirmed by pathology;
- The lower margin of the tumor was less than 12cm from the anal margin;
- Patients with clinical stage cT3-4N0M0 or cTanyN+M0;
- Newly treated patients who have not received treatment including radiotherapy, chemotherapy and surgery;
- Liver, kidney and other organs have good function and can tolerate radiotherapy, chemotherapy and surgery;
- Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.
- ECOG score \> 2;
- Patients with multiple primary colorectal cancers;
- A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the...
- Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery;
- pregnant or lactating women;
- Patients with a history of severe mental illness, immune disease, hormone medication;
- Patients contraindicated by MRI examination, chemoradiotherapy, immunotherapy or surgery;
- Participated in other clinical researchers in the past 3 months;
- Any other circumstances that the investigator considers inappropriate for inclusion.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing 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.