Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer
An Exploratory Umbrella Trial of Neoadjuvant Therapy for Locally Advanced Colorectal Cancer Based on Molecular Subtypes
1 other identifier
interventional
134
0 countries
N/A
Brief Summary
This is a prospective, open-label, single-center, phase II umbrella trial designed to evaluate the efficacy and safety of neoadjuvant therapy for locally advanced colorectal cancer. Patients will be stratified into four cohorts based on microsatellite instability (MSI) status, KRAS mutation status, and the consensus molecular subtypes (CMS). Six arms are included across four cohorts and each arm will be assigned to a specific treatment regimen. The primary endpoint is the complete response rate. Secondary endpoints include safety, organ preservation rate (for rectal cancer only), R0 resection rate, surgical complications, treatment compliance, 3-year survival, and quality of life (QoL) score.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Apr 2026
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 31, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
March 31, 2026
March 1, 2026
2 years
March 20, 2026
March 25, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Complete response (CR) rate: rate of complete response (CR), including the rate of pathologic complete response (pCR) after surgery and the rate of cCR with W&W strategy.
1 month after the surgery or 1 year after the decision of W&W.
Secondary Outcomes (10)
Adverse effects rate: proportion of participants with treatment-related adverse events as assessed by NCI-CTCAE v5.0.
From date of stratification to 3 months post-neoadjuvant therapy, an average of 8 months.
Organ preservation rate: proportion of participants who either achieve cCR and choose W&W or achieve cCR/near-cCR and choose local excision, out of the total participants who complete neoadjuvant therapy.
From date of stratification until the resection of rectum or anus, assessed up to 36 months.
R0 resection rate: proportion of surgical resections with negative margins (proximal, distal, and circumferential) on microscopic examination, with CRM negativity defined as > 1 mm from tumor bed.
1 month after the surgery.
Rate of surgical complications: rates of surgical complications such as intraoperative hemorrhage, anastomotic leakage, intestinal obstruction, etc.
within 3 months after the surgery.
Treatment compliance: treatment completion rate and delay duration during the treatment period.
From date of stratification to the completion of neoadjuvant therapy, an average of 5 months.
- +5 more secondary outcomes
Study Arms (6)
MSI-H/dMMR
EXPERIMENTALMSS-KRAS G12C-Adebrelimab
EXPERIMENTALMSS-KRAS G12C-cetuximab β
EXPERIMENTALMSS-KRAS G12D-Adebrelimab
EXPERIMENTALMSS-KRAS G12D-cetuximab β
EXPERIMENTALMSS-CMS
EXPERIMENTALInterventions
25Gy/5Fx
Oxaliplatin: 130mg/m2 d1 q3w Capecitabine: 1000mg/m2 bid d1-14 q3w
Eligibility Criteria
You may qualify if:
- Age 18-75 years old, female and male;
- Pathological confirmed adenocarcinoma;
- Stage II/III colon cancer, or stage II/III rectal cancer located less than 10 cm from the anal verge;
- Treatment-naïve and no distance metastases;
- KPS ≥ 70;
- No radiotherapy, chemotherapy, immunotherapy, or any other anti-tumor therapy had been administered prior to enrollment;
- Baseline blood and biochemical indicators meet the following criteria: neutrophils ≥ 1.5 × 10\^9/L, Hb ≥ 90 g/L, PLT ≥ 100 × 10\^9/L, ALT/ AST ≤ 2.5 ULN, Cr ≤ 1 ULN;
- With good compliance and signed the consent form.
You may not qualify if:
- Pregnancy or breast-feeding women;
- Known history of other malignancies within 5 years;
- Known history of severe neurological or mental illness (such as schizophrenia, dementia or epilepsy);
- Current severe cardiac disease (cardiac dysfunction and arrhythmia), renal dysfunction and liver dysfunction;
- Acute cardiac infarction or cerebral ischemic stroke occurred within 6 months before recruitment;
- Uncontrolled infection which needs systemic therapy;
- Active autoimmune disease or immunodeficiencies, known history of organ transplantation or systematic use of immunosuppressive agents;
- Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1 to 2 antibody positive), active syphilis infection, active pulmonary tuberculosis infection;
- Allergic to any component of the therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fudan Universitylead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Study Principal Investigator
Study Record Dates
First Submitted
March 20, 2026
First Posted
March 31, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2028
Study Completion (Estimated)
April 1, 2030
Last Updated
March 31, 2026
Record last verified: 2026-03