Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06434090
Other study ID # CSPC-DEY-CRC-K06
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date June 5, 2024
Est. completion date July 1, 2026

Study information

Verified date May 2024
Source Sun Yat-sen University
Contact Yanhong Deng, PhD
Phone 020-38379762
Email dengyanh@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 74
Est. completion date July 1, 2026
Est. primary completion date June 5, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age: =18 years old; 2. Histopathologically and/or cytologically confirmed unresectable metastatic colorectal adenocarcinoma; 3. Previous treatment with irinotecan , and have progression of disease during treatment or within three months thereafter; 4. At least one measurable lesion (according to RECIST v1.1); 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 ~ 1; 6. The expected survival time =3 months; 7. 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; 8. 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; Exclusion Criteria: 1. Any other malignancy within 5 years, with the exception of cured in-situ carcinoma or basal cell carcinoma etc; 2. Patients with the primary lesion located in the left colon and RAS/BRAF wild-type who did not use cetuximab on the first-line; 3. Patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR); 4. Massive pleural effusion or ascites requiring intervention; 5. Active, uncontrolled bacterial, viral, or fungal infections that require systemic treatment; 6. Active HIV infection; 7. Combined with uncontrollable systemic diseases within 6 months before the first administration; 8. Presence of severe gastrointestinal disease; 9. 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; 10. Presence of interstitial pneumonia or pulmonary fibrosis; 11. History of allergy or hypersensitivity to drug or any of their excipients; 12. History of pulmonary hemorrhage/hemoptysis =Grade 2 (defined as bright red blood of at least 2.5mL) within one month before the first administration; 13. 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; 14. Combined symptomatic brain metastasis, meningeal metastasis, spinal cord tumor invasion, and spinal cord compression syndrome; 15. Use of strong inhibitors or inducers of CYP3A, CYP2C8 and UGT1A1 within 14 days before the first administration; 16. 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; 17. Pregnant or breastfeeding women, or subjects of childbearing age who refuse contraception; 18. Patients who are not suitable to participate in this trial for any reason judged by the investigator;

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Liposomal irinotecan
Liposomal irinotecan will be given biweekly at a dose from 70mg/m2 to 90mg/m2.
Bevacizumab
bevacizumab will be given biweekly at a dose of 5mg/m2

Locations

Country Name City State
China The Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) of liposomal irinotecan Defined as the highest dose of DLT in<33% of subjects . 1 months
Primary Objective Response Rate Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1. 5 months
Secondary 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 . 1 months
Secondary 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. 5 months
Secondary 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. 5 months
Secondary 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. 1 years
Secondary Overall survival Defined as the time between signing the informed consent form to death due to various causes. 1 years
See also
  Status Clinical Trial Phase
Recruiting NCT05400122 - Natural Killer (NK) Cells in Combination With Interleukin-2 (IL-2) and Transforming Growth Factor Beta (TGFbeta) Receptor I Inhibitor Vactosertib in Cancer Phase 1
Active, not recruiting NCT05551052 - CRC Detection Reliable Assessment With Blood
Completed NCT00098787 - Bevacizumab and Oxaliplatin Combined With Irinotecan or Leucovorin and Fluorouracil in Treating Patients With Metastatic or Recurrent Colorectal Cancer Phase 2
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT05425940 - Study of XL092 + Atezolizumab vs Regorafenib in Subjects With Metastatic Colorectal Cancer Phase 3
Suspended NCT04595604 - Long Term Effect of Trimodal Prehabilitation Compared to ERAS in Colorectal Cancer Surgery. N/A
Completed NCT03414125 - Effect of Mailed Invites of Choice of Colonoscopy or FIT vs. Mailed FIT Alone on Colorectal Cancer Screening N/A
Completed NCT02963831 - A Study to Investigate ONCOS-102 in Combination With Durvalumab in Subjects With Advanced Peritoneal Malignancies Phase 1/Phase 2
Recruiting NCT05489211 - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03) Phase 2
Terminated NCT01847599 - Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib N/A
Completed NCT05799976 - Text Message-Based Nudges Prior to Primary Care Visits to Increase Care Gap Closure N/A
Recruiting NCT03874026 - Study of Folfiri/Cetuximab in FcGammaRIIIa V/V Stage IV Colorectal Cancer Patients Phase 2
Active, not recruiting NCT03170960 - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors Phase 1/Phase 2
Completed NCT03167125 - Participatory Research to Advance Colon Cancer Prevention N/A
Completed NCT03181334 - The C-SPAN Coalition: Colorectal Cancer Screening and Patient Navigation N/A
Recruiting NCT04258137 - Circulating DNA to Improve Outcome of Oncology PatiEnt. A Randomized Study N/A
Recruiting NCT05568420 - A Study of the Possible Effects of Medication on Young Onset Colorectal Cancer (YOCRC)
Recruiting NCT02972541 - Neoadjuvant Chemotherapy Verse Surgery Alone After Stent Placement for Obstructive Colonic Cancer N/A
Completed NCT02876224 - Study of Cobimetinib in Combination With Atezolizumab and Bevacizumab in Participants With Gastrointestinal and Other Tumors Phase 1
Completed NCT01943500 - Collection of Blood Specimens for Circulating Tumor Cell Analysis N/A