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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06215677
Other study ID # K5121
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2024
Est. completion date February 10, 2030

Study information

Verified date April 2024
Source Peking Union Medical College Hospital
Contact Zhen Sun, M.D.
Phone +86-18910598831
Email sunzhen0906@126.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 18
Est. completion date February 10, 2030
Est. primary completion date February 10, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

Drug:
Camrelizumab
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.

Locations

Country Name City State
China Peking Union Medical College Hospital Beijing Beijing
China Peking Union Medical College Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the rate of R0 resection No tumor infiltration within 1 mm of the surgical margins Tumour specimen evaluated within 2 weeks after surgery
Secondary Pathological complete response (pCR) Number of patients with pCR evaluated according to the Mandard tumour regression grading system Tumour specimen evaluated within 2 weeks after surgery.
Secondary diesease-free survival No tumor regrowth or recurrence or metastasis found 3 years
Secondary overall survival Refers to the proportion of patients still alive at 5 years after surgery 5 years
Secondary Safety and tolerability of Camrelizumab administered Determined by the incidence and severity of treatment related adverse events according to CTCAE version 5.0 Up to approximately 9 weeks
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