Can a Three-Drug combo outsmart Hard-to-Treat colorectal cancer?
NCT ID NCT06484153
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether combining three drugs—fruquintinib, pirfenidone, and pembrolizumab—can help people with advanced or metastatic colorectal cancer that has not responded to standard treatments. The study includes 25 participants with a specific type of tumor (pMMR/MSS) that typically does not respond well to immunotherapy alone. The goal is to see if this combination can slow cancer progression and improve survival, while also checking if pirfenidone helps change the tumor environment to make the immunotherapy more effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three drugs: fruquintinib (a targeted therapy), pirfenidone (an anti-fibrotic drug), and pembrolizumab (an immunotherapy).
- What this could lead to
- If successful, this combination could offer a new treatment option for people with advanced colorectal cancer who have run out of standard options, potentially slowing tumor growth and extending life.
- What could go wrong
- This is an early-phase trial with only 25 participants, so results may not apply to a larger population. The combination may cause significant side effects, and it is not yet known if it will be more effective than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Histologically confirmed diagnosis of unresectable locally advanced, recurrent or metastatic colorectal adenocarcinoma. 2. Tumor tissues were identified as mismatch repair-proficient (pMMR) by immunohistochemistry (IHC) method or microsatellite stability (MSS) by polymerase chain reaction (PCR). 3. Subjects must have failed at least two lines of prior treatment. 4. Subjects must have one measurable lesion according to RECIST v1.1 at least. 5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 6. 18-75 years old. 7\. Life expectancy of at least 12 weeks. 8. Adequate bone marrow, liver, renal and coagulation function as assessed by the laboratory required by protocol Exclusion Criteria: 1. Previously received anti-programmed death-1 (PD-1) or its ligand (PD-L1) antibody or Pirfenidone. 2. Received last dose of anti-tumor therapy (chemotherapy, targeted therapy, tumor immunotherapy or arterial embolization) within 3 weeks of the first dose of study medication. 3. Received radiotherapy with 4 weeks of the first dose of study medication. 4. Underwent major operation within 4 weeks of the first dose of study medication or open wound, ulcer or fracture. 5. Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication are permitted to enroll. 6. Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years. 7. Interstitial lung disease requiring corticosteroids. 8. Active or poorly controlled serious infections. 9. Significant malnutrition. 10. Symptomatic congestive heart failure (NYHA Class II-IV) or symptomatic or poorly controlled arrhythmia. 11. Uncontrolled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg) despite standard treatment. 12. Within 6 months prior to the enrollment, history of gastrointestinal perforation and/or fistula, gastrointestinal ulcer, bowel obstruction, extensive bowel resection, Crohn\'s disease, or ulcerative colitis, intra-abdominal abscesses, or long-term chronic diarrhea. 13. History or evidence of inherited bleeding diathesis or coagulopathy or thrombus 14. Any life-threatening bleeding within 3 months prior to the enrollment. 15. High risk of bleeding.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
RECRUITINGWuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a daily pill replace chemotherapy for advanced colorectal cancer?
- Can two immune boosters outsmart Chemo-Resistant colon cancer?
- Can a Two-Pronged attack shrink Hard-to-Treat colorectal tumors?
- Can a Two-Drug attack shrink Hard-to-Treat colorectal tumors?
- Can a four-drug cocktail shrink hard-to-treat colorectal cancer?
- Can a Drug-Radiation combo outsmart Treatment-Resistant colorectal cancer?