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

ConditionsColorectal Liver MetastasesFirst-line Treatment
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • paclitaxel cationic liposome for injection

    Drug

    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

  • Oxaliplatin

    Drug

    Oxaliplatin 130 mg/m2 i.v. on D1

  • Capecitabine

    Drug

    Capecitabine 1000 mg/m2 p.o. Bid on Day 1-14

  • Bevacizumab

    Drug

    Bevacizumab 7.5 mg/kg i.v. on D1

Treatment groups

7 Participants
are divided into 1 treatment group
Group A: Experimental armExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

The incidence of dose-limiting toxicity（DLT ）

Time frame
The first Cycle(21 days)
2

Incidence and severity of AEs and SAEs (according to NCI-CTCAE 5.0)

Time frame
Up to approximately 1 years

Secondary outcomes

1

AUC0-t

Time frame
The first four cycles ( each cycle is 21 days)
2

AUC0-∞

Time frame
The first four cycles ( each cycle is 21 days)
3

Cmax

Time frame
The first four cycles ( each cycle is 21 days)
4

Kel

Time frame
The first four cycles ( each cycle is 21 days)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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