RecruitingPhase 1

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

China7 participantsStarted 2025-05-13

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.

What they're measuring

The incidence of dose-limiting toxicity（DLT ）

Timeframe: The first Cycle(21 days)

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

Timeframe: Up to approximately 1 years

Trial details

NCT IDNCT07117435

SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-30

Contact for this trial

Clinical Trials Information Group officer

86-0311-69085587 ctr-contact@cspc.cn

View on ClinicalTrials.gov More Colorectal Liver Metastases trials