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New treatment option for Rectal Adenocarcinoma
Official title SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
ClinicalTrials.gov ID: NCT07549399
What this study is testing
What is PD-1 monoclonal antibody?
PD-1 monoclonal antibody is an investigational medicine, being studied as a potential treatment for rectal adenocarcinoma.
Also referred to as PD-1.
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
- To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.
- Phase 3: a large, late-stage study
- 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
- Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by...
- Age 18-75 years.
- Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.
- Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.
- Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).
You likely can't join if
- Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;
- A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have...
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or...
See the full eligibility criteria
- Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and...
- Age 18-75 years.
- Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.
- Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.
- Clinical staging with high-risk factors, including cT3Nx, EMVI(+), or cT4, ±MRF(+), ±EMVI(+).
- No evidence of distant metastasis before treatment.
- No prior anti-cancer treatment (radiotherapy, chemotherapy, targeted therapy, or immunotherapy).
- ECOG performance status of 0-1.
- Peripheral blood counts and liver and kidney function within the following allowable ranges (tested within 15 days before the start of treatment):
- White blood cells (WBC) ≥3.0×10\^9/L or absolute neutrophil count (ANC) ≥1.5×10\^9/L;
- Hemoglobin (HGB) ≥80 g/L; ③Platelets (PLT) ≥100×10\^9/L; ④Liver transaminases (AST/ALT) \<3.0 times the upper limit of the normal range; ⑤Total bilirubin (TBIL) \<1.5 times the upper limit of the normal range...
- No history of other malignancies; not pregnant or breastfeeding, and effective contraception must be used during the study period and for 6 months after the last dose.
- Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
- Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;
- A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;
- Severe electrolyte abnormalities;
- Presence of gastrointestinal diseases, such as active ulcers in the stomach or duodenum, ulcerative colitis, or tumors with active bleeding that have not been resected; or other conditions that may lead to...
- History of arterial thrombosis or deep vein thrombosis within 6 months; history of bleeding or evidence of bleeding tendency within 2 months; or patients receiving high-dose anticoagulation therapy;
- Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test before the first dose; or female participants and their partners who are unwilling to strictly practice contraception...
- Presence of other active malignancies (except for malignancies that have been treated with curative intent and have been disease-free for more than 3 years, or in situ cancers that can be cured with adequate treatment);
- Presence of severe ECG abnormalities or active coronary artery disease, severe/unstable angina, newly diagnosed angina or myocardial infarction within 12 months prior to study entry, or New York Heart Association (NYHA)...
- Patients with active infections (infections causing fever above 38°C);
- Patients with uncontrolled hypercalcemia, hypertension, or diabetes;
- Patients with severe pulmonary diseases (interstitial pneumonia, pulmonary fibrosis, severe emphysema, etc.);
- Patients with psychiatric disorders that may affect clinical treatment or a history of central nervous system diseases;
- Patients with severe complications (bowel obstruction, renal insufficiency, hepatic insufficiency, cerebrovascular disorders, etc.);
- Presence of any CTCAE Grade 2 or higher toxicity caused by previous treatments that has not resolved (excluding anemia, alopecia, and skin pigmentation);
- Any unstable medical condition that may affect patient safety and compliance with the study;
- Patients deemed by the investigator as unsuitable for participation in this clinical trial.
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, 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 Guangzhou, Guangdong, 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.