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Trial Title:
Envafolimab Monotherapy or Envafolimab + CAPEOX as Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
NCT ID:
NCT06014372
Condition:
Colon Cancer
Neoadjuvant Therapy
Immunotherapy
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Envafolimab
Description:
Upon confirming eligibility based on inclusion criteria and obtaining signed informed
consent, the patient will be administered Envafolimab at a dose of 300mg every 3 weeks
(Q3W) for a total of 4 cycles, starting on Day 1.
Arm group label:
Envafolimab Group
Arm group label:
Envafolimab+CAPEOX Group
Intervention type:
Drug
Intervention name:
CAPEOX
Description:
The neoadjuvant treatment regimen will consist of Oxaliplatin at a dose of 130mg/m2,
administered intravenously over a period of more than 2 hours on Day 1, every 3 weeks;
and Capecitabine at a dose of 1000mg/m2, orally, twice daily from Day 1 to Day 14, every
3 weeks, for a total of 4 cycles.
Arm group label:
Envafolimab+CAPEOX Group
Summary:
There exists substantial evidence suggesting that patients diagnosed with MSI-H/dMMR
colorectal cancer can derive benefits from immunotherapy in the management of advanced
colorectal cancer. In cases of locally advanced colorectal cancer exhibiting
microsatellite instability (dMMR/MSI-H), patients exhibit low responsiveness to
neoadjuvant chemotherapy, resulting in minimal rates of complete tumor remission and
downstaging. Nevertheless, initial exploratory studies, characterized by modest sample
sizes, reveal a favorable therapeutic effect of neoadjuvant immunotherapy in this
particular patient population. Envafolimab monoclonal antibody, the first PD-L1 antibody
developed and manufactured in China, possesses noteworthy practical and societal value in
the context of exploratory clinical research on neoadjuvant immunotherapy for locally
advanced MSI-H/dMMR colorectal cancer patients. The objective of this study is to
evaluate the safety and efficacy of envafolimab monoclonal antibody (PD-L1) as
neoadjuvant therapy for locally advanced MSI-H/dMMR colorectal cancer through a
prospective, multi-cohort phase II clinical trial. Additionally, this study aims to
investigate the effectiveness and safety of envafolimab monoclonal antibody in
combination with CAPEOX as a neoadjuvant treatment regimen for locally advanced pMMR
colorectal cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pathological confirmed rectal cancer
- Clinical stage T3-4 or T any N1
- With or without MRF positivity, with or without EMVI positivity
- R0 resection is estimated
- Age ranged from 18 to 70
Exclusion Criteria:
- Clinical stage T1-2 N0
- Distance metastasis
- Multiple primary tumor
- Cachexy
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-Sen University Cancer Center
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhen-Hai Lu, Prof.
Phone:
+86 20 87343584
Email:
luzhh@sysucc.org.cn
Contact backup:
Last name:
Rong-Xin Zhang, Prof.
Phone:
+86 20 87343456
Email:
zhangrx@sysucc.org.cn
Investigator:
Last name:
Zhen-Hai Lu, Prof.
Email:
Principal Investigator
Investigator:
Last name:
Rong-Xin Zhang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Zhi-Qiang Wang, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Yuan Li, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Fu-Long Wang, M.D
Email:
Sub-Investigator
Investigator:
Last name:
Jian-Hong Peng, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jia-Li Chen, Bachelor
Email:
Sub-Investigator
Investigator:
Last name:
Wei-Li Zhang, M.D.
Email:
Sub-Investigator
Start date:
July 1, 2023
Completion date:
July 1, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06014372
