Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18-75 years;
ECOG score 0-2;
Adenocarcinoma confirmed by pathology and dMMR confirmed by IHC or PCR;
Tumor located in cecum, ascending colon, transverse colon and sigmoid colon;
Disqualifiers
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;
Complicated with intestinal obstruction, intestinal perforation, gastrointestinal bleeding and other patients requiring emergency surgery; pregnant or lactating women;
Patients with a history of severe mental illness, immune disease, hormone medication;
Patients contraindicated by immunotherapy or surgery;
Trial design
Design model
Single group
Treatments tested in this trial
Camrelizumab
DrugCamrelizumab 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: Neoadjuvant immunotherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
the rate of R0 resection
No tumor infiltration within 1 mm of the surgical margins
Time frame
Tumour specimen evaluated within 2 weeks after surgerySecondary outcomes
1
Pathological complete response (pCR)
Number of patients with pCR evaluated according to the Mandard tumour regression grading system
Time frame
Tumour specimen evaluated within 2 weeks after surgery.2
diesease-free survival
No tumor regrowth or recurrence or metastasis found
Time frame
3 years3
overall survival
Refers to the proportion of patients still alive at 5 years after surgery
Time frame
5 years4
Safety and tolerability of Camrelizumab administered
Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0
Time frame
Up to approximately 9 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov