Colon Cancer, Immunotherapy, Mismatch Repair Deficiency
Conditions
Brief summary
Due to dMMR colon cancer patients respond poorly to conventional chemotherapy, but immunotherapy can significantly improve the pCR in this group of patients, this study intends to explore whether neoadjuvant immunotherapy can improve the R0 resection rate with preservation of adjacent organs in T4 colon cancer patients with dMMR.
Interventions
DRUGCamrelizumab
Camrelizumab 200mg for 3 cycles. Patients will undergo surgery 2-3 weeks after the last cycle of immunotherapy, type and extent of the surgery will be selected by the surgeon.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18-75 years; 2. ECOG score 0-2; 3. Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR; 4. Tumor located in cecum, ascending colon, transverse colon and sigmoid colon; 5. Patients with clinical stage cT4: (1) Loss of space between tumor and adjacent organs or invasion of adjacent organs as assessed by enhanced CT; (2) R0 resection cannot achieve according to intraoperative exploration; 6. No evidence of distant metastasis; 7. Newly treated patients who have not received treatment including chemotherapy and surgery; 8. Liver, kidney and other organs have good function and can tolerate chemotherapy and surgery; 9. Patients and family members can understand the study protocol, voluntarily participate in the study and sign informed consent.
Exclusion criteria
1. A history of other malignant tumors (other than cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically resected breast ductal carcinoma in situ) within the past 5 years; 2. Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women; 3. Patients with a history of severe mental illness, immune disease, hormone medication; 4. Patients contraindicated by immunotherapy or surgery; 5. Participated in other clinical researchers in the past 3 months; 6. Any other circumstances that the investigator considers inappropriate for inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the rate of R0 resection | Tumour specimen evaluated within 2 weeks after surgery | No tumor infiltration within 1 mm of the surgical margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological complete response (pCR) | Tumour specimen evaluated within 2 weeks after surgery. | Number of patients with pCR evaluated according to the Mandard tumour regression grading system |
| diesease-free survival | 3 years | No tumor regrowth or recurrence or metastasis found |
| overall survival | 5 years | Refers to the proportion of patients still alive at 5 years after surgery |
| Safety and tolerability of Camrelizumab administered | Up to approximately 9 weeks | Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0 |
Countries
China
Outcome results
None listed