Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal C… (NCT07683403) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Savolitinib Plus Cetuximab and FOLFOX Chemotherapy for RAS/BRAF Wild-type Metastatic Colorectal Cancer
China138 participantsStarted 2026-06-30
Plain-language summary
The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:
Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?
What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?
Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.
Participants will:
Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy
Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests
Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression
Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Voluntarily sign the informed consent form after fully understanding this study;
. Aged 18 to 75 years (inclusive), male or female;
. Have at least one measurable lesion (RECIST 1.1);
. Histologically confirmed unresectable locally advanced or metastatic colorectal cancer;
. pMMR by immunohistochemistry or unknown MMR protein expression status;
. KRAS/NRAS and BRAF all wild-type;
. c-MET IHC intensity score 2+ or 3+ in ≥50% of tumor cells in the primary lesion; or positive by FISH; or NGS copy number ≥3;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate (ORR)
Timeframe: From date of first dose of study drug until disease progression, withdrawal of consent, death, new anticancer therapy (up to approximately 24 months)
. No prior systemic therapy (Note: prior neoadjuvant or adjuvant chemotherapy is allowed if disease progression/recurrence occurred during or ≥6 months after completion of such therapy);
Exclusion criteria
. Prior treatment with anti-EGFR monoclonal antibody therapy;
. Prior treatment with c-MET small molecule inhibitors or monoclonal antibodies targeting c-MET or HGF;
. Received approved or investigational systemic anti-tumor therapy within 4 weeks prior to enrollment;
. Participated in another clinical trial of a drug not yet approved or marketed in China and received the investigational drug within 4 weeks prior to enrollment;
. Underwent any surgery or invasive treatment or procedure (except venous catheterization, puncture drainage, etc.) within 4 weeks prior to enrollment;
. INR \>1.5 or APTT \>1.5×ULN;
. Clinically significant electrolyte abnormalities as judged by the investigator;