AzTrials
AzTrials

Colorectal CancerPhase 1/2NCT06434090

Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer

A Phase 1/2 study testing Liposomal irinotecan and Bevacizumab in people with Colorectal Cancer, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Liposomal irinotecan and Bevacizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
74 participants
Where
1 siteChina
Study dates
5 Jun 2024to 1 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age: ≥18 years old；
  • Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma；
  • Previous treatment with irinotecan , and have progression of disease during treatment or within three months thereafter；
  • At least one measurable lesion (according to RECIST v1.1)；
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1；
  • The expected survival time ≥3 months；
Show all 10Show fewer
  • Adequate bone marrow function : no blood transfusion and/or use of increasing leukocyte drugs (excluding oral medication) within 14 days prior to enrollment Absolute neutrophil count (ANC) ≥1.5×109/L Platelet count ≥100×109/L Hemoglobin (Hgb) ≥90 g/L；
  • Adequate hepatic function as evidenced by:
  • Total bilirubin ≤1.5 × upper limit of normal (ULN), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN, ≤5 × ULN if liver metastases are present.
  • Serum albumin ≥30 g/L； (9Adequate renal function as evidenced by: serum creatinine (Cr) ≤1.5 × ULN or creatinine clearance ≥60 mL/min. proteinuria<2+（those with proteinuria ≥2+ at baseline had to demonstrate ≤1 g protein per 24 hours）； (10)Coagulation function: International normalised ratio (INR) ≤1.5, activated partial thromboplastin time (APTT) ≤1.5 × ULN； (11)Agree and be able to comply with the plan during the study period. Provide written informed consent before entering the study screening；

Who cannot join

  • Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc；
  • Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first-line；
  • Patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)；
  • Massive pleural effusion or ascites requiring intervention；
  • Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment；
  • Active HIV infection；
Show all 18Show fewer
  • Combined with uncontrollable systemic diseases within 6 months before the first administration；
  • Presence of severe gastrointestinal disease；
  • History of major surgery (such as laparotomy, thoracotomy or intestinal resection) within 28 days before the first administration,or plan to undergo major surgery during the study period；
  • Presence of interstitial pneumonia or pulmonary fibrosis；
  • History of allergy or hypersensitivity to drug or any of their excipients；
  • History of pulmonary hemorrhage/hemoptysis ≥Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration；
  • Presence of arterial embolism, severe bleeding (excluding bleeding caused by surgery) or tendency for existing embolism or severe bleeding within 6 months before the first administration；
  • Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome；
  • Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration；
  • Participate in other study and use study drug within 1 month or within 5 half-lives of the drug (whichever comes first) before the first administration；
  • Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception；
  • Patients who are not suitable to participate in this trial for any reason judged by the investigator；

Trial locations and contacts

1 site in 1 country.

Yanhong Deng, PhD contact

020-38379762

dengyanh@mail.sysu.edu.cn

China1 site

  • The Sixth Affiliated Hospital of Sun Yat-sen University

    Guangzhou, Guangdong, 510655

    Yanghong Deng, Phd, 02038379762, dengyanh@mail.sysu.edu.cn

Other trials in China

About this study

Official title: Liposomal Irinotecan Plus Bevacizumab in Irinotecan-refractory Metastatic Colorectal Cancer:a Multicenter, Phase I/II Trial.

To evaluate the efficacy and safety of liposomal irinotecan plus bevacizumab in irinotecan-refractory metastatic colorectal cancer

Read the detailed description

The standard treatment regimen based on irinotecan with or without bevacizumab is commonly used in metastatic colorectal cancer. With administration of traditional irinotecan, the parent drug and active metabolite SN-38 exist in the form of active lactone and carboxylate, and the lactone ring structure is unstable in neutral and alkaline solutions. In physiological pH conditions, the active lactone rapidly hydrolyzes to the inactive carboxylate, thereby reducing the efficacy, so there is certain limitation in clinical application.

Liposomes Irinotecan load the active substance irinotecan into liposomes, so that it can be slowly released in the body and achieve the effect of reducing toxicity and increasing efficacy.After being rationally designed, irinotecan liposomes can also take advantage of the high permeability and retention effect (EPR) to specifically target the tumor area, increase the amount of drug taken up by cancer cells, reduce the dosage, improve efficacy, and reduce side effects.

We are currently conducting an Phase I/II study in mCRC patients who have previously received irinotecan. After determining the maximum tolerable dose (MTD) of irinotecan liposomes in the combined regimen of irinotecan liposomes and bevacizumab, we will further explore the safety and initial efficacy of irinotecan liposomes combined with bevacizumab.

Being tested
Liposomal irinotecan, Bevacizumab
Keywords
Liposomal irinotecan, bevacizumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liposomal irinotecanDrug

    Liposomal irinotecan will be given biweekly at a dose from 70mg/m2 to 90mg/m2.

  • BevacizumabDrug

    Also called avastin

    bevacizumab will be given biweekly at a dose of 5mg/m2

Study groups in NCT06434090
Study groupRoleWhat they receive
Liposomal irinotecan plus bevacizumabExperimentalPatients received Liposomal irinotecan (a '3+3' design was adopted in the experimental arm, with 3 dose levels of 70mg/m2, 80mg/m2, and 90mg/m2 for dose exploration) every 2 weeks (Q2W). bevacizumab, 5mg/m2, every 2 weeks The two-drug combination therapy was continued every 2 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.
Receives: Drug: Liposomal irinotecan; Drug: Bevacizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) of liposomal irinotecan

    Defined as the highest dose of DLT in<33% of subjects .

    Measured: 1 months

  2. Objective Response Rate

    Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.

    Measured: 5 months

Secondary outcomes (5)

  1. Dose-Limiting Toxicities (DLT) of liposomal irinotecan

    Defined as adverse events that occur during the DLT observation period and are related to the study drug .

    Measured: 1 months

  2. Disease Control Rate

    Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.

    Measured: 5 months

  3. Duration of Response

    Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.

    Measured: 5 months

  4. Progression free Survival

    Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

    Measured: 1 years

  5. Overall survival

    Defined as the time between signing the informed consent form to death due to various causes.

    Measured: 1 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2024
  2. Study start5 Jun 2024 (estimated)
  3. Primary completion5 Jun 2025 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
74 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06434090
Sponsor's protocol ID
CSPC-DEY-CRC-K06
Status last verified
May 2024
First submitted
23 May 2024
Last updated
30 May 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Liposomal irinotecan and Bevacizumab in people with Colorectal Cancer, run by Sun Yat-sen University 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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 30 May 2024. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yanhong Deng, PhD (020-38379762, dengyanh@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) of liposomal irinotecan (time frame: 1 months). 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?

On the ClinicalTrials.gov record for NCT06434090.

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 30 May 2024; AzTrials last refreshed its copy on 8 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in