Neoadjuvant Immunotherapy for T4 dMMR Colon Cancer

Colon Cancer Clinical Trial

— NITDC  

Official title:

Efficacy of Neoadjuvant Immunotherapy for T4 Deficient Mismatch Repair (dMMR) Colon Cancer: A Prospective, Single-arm, Phase Ⅱ Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06215677
• Other study ID #: K5121
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Immunotherapy
• Mismatch Repair Deficiency

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