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New treatment option for Rectal Cancer
Official title Planed Organ Preservation for Low Rectal Cancer After Neoadjuvant Chemotherapy (OPLAR)
ClinicalTrials.gov ID: NCT07070622
What this study is testing
What is patients were assigned to receive TNT or iTNT management?
patients were assigned to receive TNT or iTNT management is an investigational medicine, 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
- 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.
- Phase 3: a large, late-stage study
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
- Age: 18-80 years old; Gender is not limited;
- rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;
- The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The distance between the lower edge of...
- ECOG score: 0-1;
- Patients with primary rectal cancer did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment;
You likely can't join if
- patients with lynch syndrome;
- Distant metastasis was not considered at initial diagnosis but proved during treatment;
- previous or concurrent history of other malignant tumors (including synchronous colon cancer), except cured basal cell carcinoma of the skin and...
- patients who had received pelvic radiotherapy;
- pregnant or lactating women with fertility needs; Male patients with fertility needs;
- The presence of uncontrolled systemic diseases as determined by the investigator, including diabetes mellitus, hypertension, active autoimmune...
See the full eligibility criteria
- Age: 18-80 years old; Gender is not limited;
- rectal adenocarcinoma confirmed by pathology and pMMR/MSS by immunohistochemistry and/or genetic testing;
- The following characteristics of the tumor were evaluated by thoracoabdominal CT, rectal ultrasound and MRI: ① The distance between the lower edge of the tumor and the anal verge was ≤5cm measured by digital rectal...
- ECOG score: 0-1;
- Patients with primary rectal cancer did not receive surgery, radiotherapy, chemotherapy or other anti-tumor treatment before enrollment;
- Normal main organ function, which met the following characteristics: ① Blood routine examination criteria: HB ≥9g/dL, WBC ≥ 3.5/4.0×109/L, neutrophil ≥ 1.5×109/L, PLT≥ 100×109/L; ② Biochemical examination should meet...
- No history of allergy to 5-Fu or platinum drugs; Women of childbearing age were required to have a negative pregnancy test (serum or urine) 7 days before enrollment and to be willing to use an appropriate method of...
- patients with lynch syndrome;
- Distant metastasis was not considered at initial diagnosis but proved during treatment;
- previous or concurrent history of other malignant tumors (including synchronous colon cancer), except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix;
- patients who had received pelvic radiotherapy;
- pregnant or lactating women with fertility needs; Male patients with fertility needs;
- The presence of uncontrolled systemic diseases as determined by the investigator, including diabetes mellitus, hypertension, active autoimmune diseases or a history of autoimmune diseases (e.g., interstitial pneumonia...
- those with mental disorders;
- Severe infection (CTCAE \> 2) occurred within 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Patients with active pulmonary...
- patients with bleeding diathesis or coagulopathy were on thrombolytic/anticoagulant therapy; Aneurysm, stroke, transient ischemic attack, arteriovenous malformation in the past year;
- serious gastrointestinal diseases affecting the absorption of oral chemotherapy drugs, and a history of gastrointestinal fistula, perforation, bleeding or severe ulcer;
- a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, or organ transplantation or allogeneic bone marrow transplantation;
- patients with a history of interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung disease, active pulmonary tuberculosis infection detected by medical history or CT...
- known allergic to macromolecular protein preparations, or to any component of tislelizumab, or allergic, hypersensitive, or contraindicated to etoposide or cisplatin or any component used in their preparations;
- have received or are receiving any of the following therapies: a. Anti-pd-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy; b. received any study drug within 4 weeks before the first dose...
- enrolled in an additional clinical trial within 4 weeks before initiation of treatment.
The study team makes the final eligibility decision.
Where it's taking place
- Chengdu, Sichuan, 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 Chengdu, Sichuan, 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.