Cadonilimab + FOLFOX Versus FOLFOX in the Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer

Locally Advanced Colorectal Carcinoma Clinical Trial

Official title:

Comparison of Cetuximab Combined With Chemotherapy Versus Chemotherapy Alone in the Neoadjuvant Treatment of Locally Advanced pMMR/MSS Colorectal Cancer: a Randomized, Open-label, Single-center Phase II Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06154538
• Other study ID #: CancerIHCAMS-NCTplusAK104
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2023
• Est. completion date: November 1, 2028

Study information

• Verified date: November 2023
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Qian Liu
• Phone: +8618610506948
• Email: fcwpumch[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the efficacy and safety of the combination of Cadonilimab and FOLFOX regimen compared to FOLFOX regimen alone in the neoadjuvant chemotherapy of pMMR/MSS locally advanced colorectal cancer. The main question aims to answer are:

Question 1: Compare the pathological complete response rate between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.

Question 2: Compare the survival outcomes and safety between the combination of Cadonilimab and FOLFOX regimen and the FOLFOX alone.

Two groups of participants will receive different new adjuvant chemotherapy regimens, and their efficacy will be compared.

Description:

A prospective, randomized, open, single-center clinical study evaluating the efficacy (pathological response, survival outcomes) and safety of the combination of Cadonilimab and FOLFOX regimen compared to FOLFOX regimen in the treatment of locally advanced colorectal cancer with proficient mismatch-repair (pMMR) or microsatellite stable (MSS) protein expression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 170
• Est. completion date: November 1, 2028
• Est. primary completion date: November 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age 18 to 75, no gender restrictions;

• Histologically or cytologically confirmed colorectal adenocarcinoma;

• Clinically diagnosed as stage II/III colorectal cancer based on CT and/or MRI (according to the 8th edition of AJCC staging);

• Sufficient tumor tissue specimens for mismatch repair protein expression or microsatellite instability testing, with mismatch repair protein expression result of pMMR, or microsatellite instability testing result of MSS;

• No prior systemic drug therapy and/or radiotherapy for colorectal adenocarcinoma;

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;

• Normal major organ function, no severe blood, heart, lung, liver, kidney dysfunction, or immune deficiency diseases (see protocol for details);

• Voluntary participation in this study and signed informed consent form;

• Expected good compliance to complete the study treatment, follow-up for efficacy and adverse reactions according to the protocol requirements.

Exclusion Criteria:

• Pathology is adenocarcinoma but mismatch repair protein expression result is dMMR, or microsatellite instability testing result is MSI-H; or pathology is other malignant tumors besides adenocarcinoma, such as squamous cell carcinoma, gastrointestinal stromal tumor, melanoma, etc.;

• Within 5 years prior to the first use of investigational drug, diagnosed with other malignant tumors, excluding effectively treated basal cell carcinoma, squamous cell carcinoma of the skin, and/or in situ cervical cancer and/or breast cancer effectively removed;

• Any distant metastatic colorectal adenocarcinoma (according to AJCC 8th edition staging, determined as M1), including but not limited to distant lymph node metastasis, liver metastasis, lung metastasis, intraperitoneal dissemination, or malignant peritoneal effusion;

• Various severe underlying diseases and autoimmune diseases (see protocol for details);

• Unable to control recurrent bleeding or subjects who received blood transfusion within 2 weeks prior to the first use of investigational drug;

• Any other circumstances where the investigator believes it may increase the risk associated with participating in the study, the administration of the investigational drug, or affect the subject's ability to receive the investigational drug and the reliability of the study results.

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Locally Advanced Colorectal Carcinoma

Intervention

Drug:
• Cadonilimab
PD-1/CTLA-4 bi-specific antibody
• FOLFOX regimen
FOLFOX chemotherapy

Locations

Country	Name	City	State
China	Cancer Hospital/ National Cancer Center, Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	adverse event adverse event rate	adverse event	90 days
Other	treatment-related adverse event	treatment-related adverse event	90 days
Other	serious adverse event	serious adverse event	90 days
Primary	pCR rate	pathological complete response rate	at time of surgery
Secondary	R0 resection rate	R0 resection rate	at time of surgical assessment (after 3 cycles), up to 12 months
Secondary	DFS	disease-free survival	up to 3 years after intervention
Secondary	3 years DFS rate	3 years DFS rate	3 years
Secondary	OS	overall survival	at 1,2,3 years at follow-up time