Colorectal Liver MetastasesPhase 1NCT07117435
Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
A Phase 1 study testing paclitaxel cationic liposome for injection, Oxaliplatin and Capecitabine in people with Colorectal Liver Metastases and First-line Treatment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Liver Metastases, First-line Treatment
- What is being tested?
- paclitaxel cationic liposome for injection, Oxaliplatin and Capecitabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteChina
- Study dates
- 13 May 2025to 1 Jun 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Age range: 18 - 75 years old (inclusive), gender not limited.
- 2. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:
- Have not received systemic treatment for the metastatic or recurrent disease;
- For patients who have received neoadjuvant/adjuvant therapy before, the time interval between the last administration and disease progression must be ≥ 6 months;
- Allow patients who have received local treatment and progressed.
- 3. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).
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- 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- 5. Life expectancy of at least 3 months.
- 6. Adequate organ function, with laboratory tests meeting the following criteria (no blood transfusion or hematopoietic growth factors within 14 days)
- 7. Fertile patients (male and female) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the study and for at least 6 months after the last dose of study intervention. Women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
- 8. Fully understand the clinical study and voluntarily sign a written informed consent form.
Who cannot join
- 1. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.
- 2. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.
- 3. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).
- 4. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigators judges that the patient is not suitable for enrollment.
- 5. Patients with contraindications for transcatheter arterial infusion.
- 6. Patients with active infections within 2 weeks prior to administration (NCI CTC AE v5.0 ≥ grade 2) (Defined as requiring intravenous administration of antibacterial, antifungal or antiviral drugs for treatment).
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- 7. Patients with grade 2 or above peripheral neuropathy (NCI CTC AE v5.0).
- 8. Patients with a history of autoimmune diseases, immunodeficiency disorders, including HIV positive test results, or suffering from other acquired or congenital immune deficiencies, or those currently using immunosuppressive agents.
- 9. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive with HBV DNA ≥ 2×103 IU/mL (can use continuous antiviral treatment); or anti-hepatitis C virus antibody (HCV-Ab) positive with HCV RNA above the measurable limit; or active syphilis.
- 10. Patients with known contraindications to capecitabine or oxaliplatin, paclitaxel or cationic liposome, or have severe allergic reactions; note: If the subject has contraindications to bevacizumab or has severe allergic reactions to any component of bevacizumab, it will not affect the enrollment but should not use bevacizumab in the study, and the specific reasons need to be recorded.
- 11. Patients need to receive strong inducers and strong inhibitors of CYP2C8 and CYP3A4 within 2 weeks before the first study treatment or during the treatment.
- 12. Patients had or have non-infectious pneumonia/interstitial lung disease that requires systemic glucocorticoid treatment.
- 13. Severe cardiovascular disease history, including but not limited to:
- Long QT syndrome;
- High-degree atrioventricular block;
- Severe arrhythmia that is not well controlled by medication;
- Chronic heart failure history and NYHA cardiac function classification ≥ 3;
- Severe valvular regurgitation or stenosis that requires treatment;
- Acute coronary syndrome or severe myocardial disease within 6 months before screening;
- Uncontrolled hypertension;
- Echocardiography suggests LVEF < 50%;
- 14. Patients with a previous history of severe neurological or mental disorders (including epilepsy or dementia) lead to compliance issues.
- 15. Patients with ultrasound-detected limb vascular thrombosis with potentially serious consequences during screening, or who with thromboembolic events within 3 months prior to enrollment.
- 16. Patients with a history of severe bleeding, or who experienced major bleeding events such as intracranial hemorrhage, gastrointestinal bleeding, or purpura within the last 3 months.
- 17. Any other reasons deemed by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Sun Yat-sen University，Lishui Central Hospital
Lishui, Zhejiang
Jiansong Ji, Doctor of Meicine, 86-13857088508, jjstcty@sina.com
About this study
Official title: A Phase Ib/III Study to Evaluate the Safety and Efficacy of Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
Read the detailed description
This study includes 2 parts. In Phase Ib part of this study, paclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose from the low-level to the high-level, with the first cycle (21 days) being the DLT observation period. In the Phase III part of this study, participants will be randomized in 1:1 ratio to receive either hepatic arterial infusion of paclitaxel cationic liposome (at the dose to be determined in the Phase Ib) in combination with systemic therapy or systemic therapy.
The primary purpose of the Phase Ib part of this study is to determine the recommended Phase III dose (RP3D) of paclitaxel cationic liposome administered via hepatic arterial infusion on Day 15 of each 3-week cycle.
The primary purpose of the Phase III part of this study is to measure the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
- Conditions
- Colorectal Liver Metastases, First-line Treatment
- Being tested
- paclitaxel cationic liposome for injection, Oxaliplatin, Capecitabine, Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel cationic liposome for injectionDrug
Paclitaxel cationic liposome was administered through hepatic arterial catheter infusion, in a gradual increment dose range from 33 mg/m^2 to 55 mg/m^2
OxaliplatinDrug
Oxaliplatin 130 mg/m2 i.v. on D1
CapecitabineDrug
Capecitabine 1000 mg/m2 p.o. Bid on Day 1-14
BevacizumabDrug
Bevacizumab 7.5 mg/kg i.v. on D1
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm | Experimental | Paclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose range from 33 mg/m^2 to 55 mg/m^2, combined with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) Receives: Drug: paclitaxel cationic liposome for injection; Drug: Oxaliplatin; Drug: Capecitabine; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose-limiting toxicity（DLT ）
Measured: The first Cycle(21 days)
Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)
Measured: Up to approximately 1 years
Secondary outcomes (14)
AUC0-t
Measured: The first four cycles ( each cycle is 21 days)
AUC0-∞
Measured: The first four cycles ( each cycle is 21 days)
Cmax
Measured: The first four cycles ( each cycle is 21 days)
Kel
Measured: The first four cycles ( each cycle is 21 days)
Tmax
Measured: The first four cycles ( each cycle is 21 days)
Vz
Measured: The first four cycles ( each cycle is 21 days)
t1/2
Measured: The first four cycles ( each cycle is 21 days)
CL
Measured: The first four cycles ( each cycle is 21 days)
Overall response rate（ORR）
Measured: Up to approximately 1 years
Disease control rate（DCR）
Measured: Up to approximately 1 years
Duration of Response（DoR）
Measured: Up to approximately 1 years
Progression-Free-Survival（PFS）
Measured: Up to approximately 2 years
Time to Progression（TTP）
Measured: Up to approximately 2 years
Overall survival（OS）
Measured: Up to approximately 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start13 May 2025
- Primary completion30 Dec 2025 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Liver MetastasesStudies of the same condition, open and under way.
- More trials run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd.The sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants receive the same treatment, and there is no comparison group.
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07117435
- Sponsor's protocol ID
- HA131-004
- Status last verified
- Aug 2025
- First submitted
- 5 Aug 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/III Study to Evaluate the Safety and Efficacy of Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases
- ClinicalTrials.gov ID
- NCT07117435
- Acronym / sponsor ID
- HA131-004
- Conditions
- Colorectal Liver Metastases, First-line Treatment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 May 2025 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase Ib/III, randomized, multicenter study evaluating the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
Detailed description
This study includes 2 parts. In Phase Ib part of this study, paclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose from the low-level to the high-level, with the first cycle (21 days) being the DLT observation period. In the Phase III part of this study, participants will be randomized in 1:1 ratio to receive either hepatic arterial infusion of paclitaxel cationic liposome (at the dose to be determined in the Phase Ib) in combination with systemic therapy or systemic therapy.
The primary purpose of the Phase Ib part of this study is to determine the recommended Phase III dose (RP3D) of paclitaxel cationic liposome administered via hepatic arterial infusion on Day 15 of each 3-week cycle.
The primary purpose of the Phase III part of this study is to measure the efficacy and safety of hepatic arterial infusion of paclitaxel cationic liposome in combination with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) as first-line treatment in colorectal liver metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants receive the same treatment, and there is no comparison group.
| Arm | Type | Receives |
|---|---|---|
| Experimental arm | Experimental | Drug: paclitaxel cationic liposome for injection, Drug: Oxaliplatin, Drug: Capecitabine, Drug: BevacizumabPaclitaxel cationic liposome was administered via hepatic arterial infusion on Day 15 of each 3-week cycle, and in a gradual increment dose range from 33 mg/m^2 to 55 mg/m^2, combined with systemic therapy (Oxaliplatin, Capecitabine, with or without Bevacizumab) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Age range: 18 - 75 years old (inclusive), gender not limited.
- 2. For patients with colorectal liver metastases have been histologically or cytologically confirmed and who are assessed by multidisciplinary team (MDT) to be inoperable for radical surgical resection:
- 3. According to RECIST v1.1, at least one measurable lesion in the hepatic arterial infusion area (long diameter ≥ 1 cm and no previous local treatment).
- 4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
- 5. Life expectancy of at least 3 months.
Key exclusion criteria (25 listed)
- 1. Patients known to have microsatellite instability high (MSI-H) or mismatch repair deficiency (dMMR), and have been evaluated by the investigators to be eligible for immune checkpoint inhibitor therapy.
- 2. Patients known to have wild-type RAS and BRAF, and have been evaluated by the investigators to be eligible for anti-epidermal growth factor receptor (EGFR) drug therapy.
- 3. Unresolved adverse reactions from previous anti-tumor treatments not yet recovered to CTCAE 5.0 grade ≤ 1 (except for alopecia or other toxicities deemed non-risky by the investigators).
- 4. Central nervous system metastasis with clinical symptoms, or meningeal metastasis, or there are other evidences indicating that the patient's central nervous system metastasis or meningeal metastatic lesions have not been controlled, and the investigators judges that the patient is not suitable for enrollment.
- 5. Patients with contraindications for transcatheter arterial infusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxel cationic liposome for injectionPaclitaxel cationic liposome was administered through hepatic arterial catheter infusion, in a gradual increment dose range from 33 mg/m^2 to 55 mg/m^2 | Drug | Experimental arm |
| OxaliplatinOxaliplatin 130 mg/m2 i.v. on D1 | Drug | Experimental arm |
| CapecitabineCapecitabine 1000 mg/m2 p.o. Bid on Day 1-14 | Drug | Experimental arm |
| BevacizumabBevacizumab 7.5 mg/kg i.v. on D1 | Drug | Experimental arm |
Primary outcome
The incidence of dose-limiting toxicity（DLT ）
Time frame: The first Cycle(21 days)
Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)
Time frame: Up to approximately 1 years
14 secondary outcomes
AUC0-t
Time frame: The first four cycles ( each cycle is 21 days)
AUC0-∞
Time frame: The first four cycles ( each cycle is 21 days)
Cmax
Time frame: The first four cycles ( each cycle is 21 days)
Kel
Time frame: The first four cycles ( each cycle is 21 days)
Tmax
Time frame: The first four cycles ( each cycle is 21 days)
Vz
Time frame: The first four cycles ( each cycle is 21 days)
t1/2
Time frame: The first four cycles ( each cycle is 21 days)
CL
Time frame: The first four cycles ( each cycle is 21 days)
Overall response rate（ORR）
Time frame: Up to approximately 1 years
Disease control rate（DCR）
Time frame: Up to approximately 1 years
Duration of Response（DoR）
Time frame: Up to approximately 1 years
Progression-Free-Survival（PFS）
Time frame: Up to approximately 2 years
Time to Progression（TTP）
Time frame: Up to approximately 2 years
Overall survival（OS）
Time frame: Up to approximately 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing paclitaxel cationic liposome for injection, Oxaliplatin and Capecitabine in people with Colorectal Liver Metastases and First-line Treatment, run by CSPC ZhongQi Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose-limiting toxicity（DLT ） (time frame: The first Cycle(21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.