Patients With Metastatic Colorectal Cancer Who Were TP53-mutant and LRPPRC-positive and Had Previously Failed Prior First-line TreatmentPhase 2NCT07337551
Gossypol Acetate + FOLFIRI + Bev in mCRC With TP53-Mutant and LRPPRC Positive
A Phase 2 study testing Gossypol acetate Combined with Bevacizumab and FOLFIRI in people with Patients With Metastatic Colorectal Cancer Who Were TP53-mutant and LRPPRC-positive and Had Previously Failed Prior First-line Treatment, run by Guiying Wang.
Trial summary
This study is a single-center, single-arm clinical trial involving patients with TP53-mutated and LRPPRC-positive metastatic colorectal cancer. It aims to evaluate the efficacy and safety of gossypol acetate tablets combined with bevacizumab and the FOLFIRI regimen as a second-line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With Metastatic Colorectal Cancer Who Were TP53-mutant and LRPPRC-positive and Had Previously Failed Prior First-line Treatment
- What is being tested?
- Gossypol acetate Combined with Bevacizumab and FOLFIRI
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Feb 2028
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years.
- Histopathologically or cytologically confirmed adenocarcinoma of the colon or rectum.
- Radiologically confirmed unresectable metastatic disease.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Prior first-line treatment with an oxaliplatin-based regimen.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
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- Life expectancy ≥3 months.
- 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.
- 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.
- 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+.
- Normal coagulation function: international normalized ratio (INR) ≤1.5.
- Ability to understand the study requirements; voluntary provision of written informed consent by the patient and/or legal representative.
Who cannot join
- 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).
- Patients previously subjected to irinotecan or irinotecan liposome-based chemotherapy.
- Presence of massive pleural effusion or ascites requiring therapeutic intervention.
- 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.
- 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).
- 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.
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- Presence of severe gastrointestinal diseases (including active bleeding, obstruction greater than Grade 1, diarrhea greater than Grade 1, or gastrointestinal perforation).
- History of laparotomy, thoracotomy, or intestinal resection within 28 days prior to enrollment.
- Presence of interstitial lung disease or pulmonary fibrosis.
- Known allergy or intolerance to the investigational drug(s) or their excipients.
- History of pulmonary hemorrhage/hemoptysis ≥ Grade 2 (defined as at least 2.5 mL of bright red blood) within one month prior to enrollment.
- 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.
- Presence of central nervous system metastases.
- Serum albumin level ≤ 3 g/dL.
- Concomitant use of strong inhibitors or inducers of CYP3A4, CYP2C8, or UGT1A1.
- Pregnant or lactating women, as well as patients of childbearing potential who refuse to adopt adequate contraceptive measures during the trial.
- Participation in another clinical trial within 30 days prior to the first dose of the investigational drug.
- Allergy to bevacizumab, irinotecan, fluorouracil, calcium folinate, or compound gossypol acetate tablets.
- Patients deemed by the investigator to be unsuitable for participation in this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Gossypol Acetate Combined With Bevacizumab and FOLFIRI as Second-Line Therapy for Metastatic Colorectal Cancer With TP53 Mutation and LRPPRC Positivity: A Single-Center, Single-Arm Clinical Study
This study is a single-center, single-arm clinical trial involving patients with TP53-mutated and LRPPRC-positive metastatic colorectal cancer. It aims to evaluate the efficacy and safety of gossypol acetate tablets combined with bevacizumab and the FOLFIRI regimen as a second-line treatment. The study is based on a key scientific finding: LRPPRC is a critical protein mediating chemotherapy resistance induced by TP53 mutation, and gossypol acetate-an existing drug-can specifically degrade LRPPRC. Preclinical studies have demonstrated its potential to effectively reverse drug resistance.
Patients who have experienced failure of first-line oxaliplatin-based therapy are planned to be enrolled. All eligible subjects will receive the same combined treatment regimen until disease progression or unacceptable toxicity occurs. The primary endpoint is objective response rate (ORR), and secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety. Throughout the treatment period, patients will undergo regular tumor imaging evaluations and safety monitoring. Statistical analyses will be performed using both the full analysis set and the per-protocol set.
This study strictly adheres to ethical standards and aims to explore a new potential treatment strategy for this specific refractory patient population.
- Being tested
- Gossypol acetate Combined with Bevacizumab and FOLFIRI
- Keywords
- TP53 mutant, LRPPRC positive, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gossypol acetate Combined with Bevacizumab and FOLFIRIDrug
Gossypol Acetate Oral 20mg/day
| Study group | Role | What they receive |
|---|---|---|
| GAA+FOLFIRI + Bev | Experimental | Not described Receives: Drug: Gossypol acetate Combined with Bevacizumab and FOLFIRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Endpoint
Objective Response Rate (ORR)
Measured: up to 16 months
Secondary outcomes (6)
Secondary Endpoints
Progression-Free Survival (PFS)
Measured: up to 16 months
Secondary Endpoints
Clinical Benefit Rate (CBR)
Measured: up to 16 months
Secondary Endpoints
Duration of Response (DoR)
Measured: up to 16 months
Secondary Endpoints
Time to Response (TTR)
Measured: up to 16 months
Secondary Endpoints
Overall Survival (OS)
Measured: up to 16 months
Secondary Endpoints
Adverse Events (AE)
Measured: up to 16 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients With Metastatic Colorectal Cancer Who Were TP53-mutant and LRPPRC-positive and Had Previously Failed Prior First-line TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guiying Wang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guiying Wang, The Second Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337551
- Sponsor's protocol ID
- 2025-R689
- Status last verified
- Jan 2026
- First submitted
- 27 Aug 2025
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No