Status:
RECRUITING
Safety and Efficacy of PD-1 ± mFOLFOX6 Neoadjuvant Therapy in Local Advanced sMPCC
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Multiple Cancer
Colorectal Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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 ha...
Detailed Description
Colorectal cancer is one of the most common malignant tumors in the world. At present, radical resection ± preoperative neoadjuvant chemotherapy for colorectal cancer is still the standard comprehensi...
Eligibility Criteria
Inclusion
- 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 by polymerase chain reaction or next-generation sequencing technique;
- 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 shape and MRI character, clinical data should be re-evaluated and judged by center evaluation group when there are contradictory stagings，distant metastasis were excluded by chest and abdominal enhanced CT and pelvic enhanced MRI;
- 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.
Exclusion
- 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 grade II;
- 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 bronchodilators);
- 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.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06002789
Start Date
May 1 2022
End Date
December 1 2028
Last Update
January 22 2025
Active Locations (1)
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1
The Sixth Affiliated Hospital, Sun Yatsen University
Guangzhou, Guangdong, China