Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
Recruiting
Phase 3
Interventional Study
Rectal Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 186 (estimated)
- Sponsor
- West China Hospital · Other
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About This Trial
On the basis of our previous study, this project further explored whether patients with effective neoadjuvant chemotherapy can obtain a higher organ preservation rate after total neoadjuvant therapy. This study was designed to enroll patients with low and intermediate-risk rectal cancer. After 2 cycles of XELOX chemotherapy, patients with effective chemotherapy as judged by high-definition MRI of …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age: 18-80 years old; Gender is not limited;
2. rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;
3. The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The dist…
Contacts