Could a Cottonseed-Derived drug help beat Chemo-Resistant colon cancer?
NCT ID NCT07337551
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tests a combination of gossypol acetate (a drug from cottonseed), bevacizumab, and FOLFIRI chemotherapy in 20 people with metastatic colorectal cancer that has a TP53 mutation and is LRPPRC-positive. The goal is to see if this mix can shrink tumors or slow the cancer after first-line treatment has failed. The study is based on lab findings that gossypol acetate may help reverse drug resistance.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gossypol acetate combined with bevacizumab and FOLFIRI (chemotherapy)
- What this could lead to
- If it works, this could offer a new second-line treatment option for people with a specific type of metastatic colorectal cancer that has stopped responding to first-line therapy.
- What could go wrong
- This is a very early, small study with only 20 participants and no comparison group. The combination may not work better than existing options, and side effects from the drugs could be significant.
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 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
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 years and older
- Sex
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Female participants only
- 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. Female patients aged ≥18 years. 2. Histopathologically or cytologically confirmed adenocarcinoma of the colon or rectum. 3. Radiologically confirmed unresectable metastatic disease. 4. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. 5. Prior first-line treatment with an oxaliplatin-based regimen. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 7. Life expectancy ≥3 months. 8. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5×10⁹/L, platelet count (PLT) ≥100×10⁹/L, hemoglobin (Hb) ≥90 g/L, and white blood cell count (WBC) ≥3.0×10⁹/L. 9. Adequate liver function: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP) ≤2.5 × the upper limit of normal (ULN), or ≤5×ULN in the presence of liver metastases; total bilirubin ≤1.5×ULN. 10. Adequate renal function: serum creatinine (Cr) ≤1.5×ULN or creatinine clearance ≥60 mL/min (calculated using the Cockcroft-Gault formula), and urine protein \<2+. 11. Normal coagulation function: international normalized ratio (INR) ≤1.5. 12. Ability to understand the study requirements; voluntary provision of written informed consent by the patient and/or legal representative. Exclusion Criteria: 1. Patients with a history of other malignant tumors within the past 5 years (except cured carcinoma \*in situ\* or basal cell carcinoma of the skin). 2. Patients previously subjected to irinotecan or irinotecan liposome-based chemotherapy. 3. Presence of massive pleural effusion or ascites requiring therapeutic intervention. 4. Active, uncontrolled bacterial, viral, or fungal infection requiring systemic treatment, defined as persistent signs/symptoms related to the infection without improvement despite appropriate antibiotic, antiviral, and/or other therapy. 5. Known active HIV infection (i.e., positive for HIV-1/2 antibodies); untreated active HBV infection (defined as positive for HBsAg or HBcAg with detectable HBV-DNA copies exceeding the upper limit of normal \[ULN\] at the local laboratory) and active HCV infection (positive for HCV antibody with an HCV-RNA level above the ULN). 6. Concurrent uncontrolled systemic diseases, including cardiovascular disorders such as unstable angina, myocardial infarction, congestive heart failure, severe unstable ventricular arrhythmias, or a history of severe pericardial disease; uncontrolled hypertension (defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg after standardized antihypertensive therapy) or a history of hypertensive crisis or hypertensive encephalopathy; uncontrolled diabetes mellitus, etc. 7. Presence of severe gastrointestinal diseases (including active bleeding, obstruction greater than Grade 1, diarrhea greater than Grade 1, or gastrointestinal perforation). 8. History of laparotomy, thoracotomy, or intestinal resection within 28 days prior to enrollment. 9. Presence of interstitial lung disease or pulmonary fibrosis. 10. Known allergy or intolerance to the investigational drug(s) or their excipients. 11. History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as at least 2.5 mL of bright red blood) within one month prior to enrollment. 12. History of arterial thromboembolism, severe hemorrhage (excluding bleeding due to surgery), or current predisposition to embolism or severe hemorrhage within 6 months prior to enrollment. 13. Presence of central nervous system metastases. 14. Serum albumin level ≤ 3 g/dL. 15. Concomitant use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1. 16. Pregnant or lactating women, as well as patients of childbearing potential who refuse to adopt adequate contraceptive measures during the trial. 17. Participation in another clinical trial within 30 days prior to the first dose of the investigational drug. 18. Allergy to bevacizumab, irinotecan, fluorouracil, calcium folinate, or compound gossypol acetate tablets. 19. Patients deemed by the investigator to be unsuitable for participation in this study.
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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 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.