BridgeMD
Tests treatment safety and results for Multiple Cancer
Official title Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC
ClinicalTrials.gov ID: NCT06002789
What this study is testing
What is MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy?
MSI-H/MSS (dMMR/pMMR) mixed sMPCC: combination of mFOLFOX6+PD-1 monoclonal antibody neoadjuvant therapy is an investigational medicine, being studied as a potential treatment for multiple cancer.
Also referred to as Mixed sMPCC.
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
- At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensive treatment. In recent years, immunotherapy of PD-1 monoclonal antibody has a significant effect in the second-line/first-line treatment of dMMR/MSI-H advanced colorectal cancer and the neoadjuvant treatment of early colorectal cancer.
- 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
- Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);
- Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins...
- Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;
- Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric...
- No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;
You likely can't join if
- Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial...
- Severe hypertension not well controlled by drugs;
- HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);
- Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;
- Other active clinical severe infection(NCI-CTC AE V5.0);
- Outside pelvic distant metastasis evidences;
See the full eligibility criteria
- Histological confirmation of simultaneous multiple primary colorectal cancer (sMPCC);
- Tumor biopsy immunohistochemistry of at least one tumor lesion identified dMMR, including the expression loss of one or more of the four proteins MSH1, MSH2, MSH6 and PMS2; or at least one tumor lesion identified MSI-H...
- Clinical staging T3-4NxM0, with or without positive MRF, with or without positive EMVI;
- Staging method: all patients undergo chest,abdominal and pelvic enhanced CT, rectal palpation, high resolution MRI examination，positive perienteric lymph node(LN): short diameter ≥10mm LN or LN with typical metastatic...
- No intestinal obstruction symptom，or obstruction relieved after proximal colostomy;
- No colorectal surgery history;
- No chemotherapy or radiotherapy history;
- No biopharmaceutical treatment history(such as monoclonal antibody), immunotherapy(such as anti PD-1antibody, anti PD-L1 antibody, anti PD-L2 antibody or anti CTLA-4), or other research drug treatment;
- No endocrinotherapy history restriction;
- informed consent assigned.
- Arrhythmia need anti-arrhythmia treatment(except β-blocking agent or Digoxin), symptomatic coronary heart disease or myocardial ischemia(myocardial infarction within 6 months) or congestive heart-failure (CHF) \> NYHA...
- Severe hypertension not well controlled by drugs;
- HIV infection history or active phase of chronic Hepatitis B or C(high copies of virus DNA);
- Active tuberculosis(TB), accepting anti-TB treatment or anti-TB treatment within 1 year before trial screen;
- Other active clinical severe infection(NCI-CTC AE V5.0);
- Outside pelvic distant metastasis evidences;
- Dyscrasia, organ dysfunction;
- Pelvic or abdominal radiotherapy history;
- Epilepsy need treatments(Steroid or anti-epilepsy therapy);
- Other malignant tumor history within 5 years;
- Over abuse of drugs, medical and psychological or social conditions that might interfere patients or evaluation of the study results;
- Any active autoimmune disease or autoimmune disease history (including but not restricted: interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, nephritis, hyperthyroidism, hypothyroidism, asthma need...
- Any anti-infection vaccine injection 4 weeks before inclusion;
- Long-term exposure to immune-suppressor, combination of systemic or topical use of corticosteroids (dose\>10mg/day prednisolone or equivalent hormone);
- Known or suspicious allergy to any study related drugs;
- Any unstable state might cause damage to the safety and compliance of patients;
- Pregnant or breast feeding women who has ability to have children while without contraception;
- Refuse to sign informed consent.
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 80 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.