Paclitaxel Cationic Liposome (Hepatic Arterial Infusion) in Combination With Systemic Therapy as First-Line Treatment in Colorectal Liver Metastases

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

1. Age range: 18 - 75 years old (inclusive), gender not limited.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • paclitaxel cationic liposome for injection
  • Oxaliplatin
  • Capecitabine
  • Bevacizumab

Treatment groups

7 Participants
are divided into 1 treatment group