Colorectal CancerNCT06443307
Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
An observational study of Colorectal Cancer and Solid Tumor, run by Peking University at 1 site in China.
Trial summary
This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Solid Tumor
- What is being tested?
- Irinotecan Liposome
- How many people
- 933 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2024to 1 Aug 2026
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study was a prospective, multicenter real-world study with four cohorts. Cohort 1 include patients as second-line treatment for metastatic colorectal cancer. Cohort 2 include patients as a late-line treatment for metastatic colorectal cancer. Cohort 3 include patients as neoadjuvant chemotherapy for colorectal cancer. Cohort 4 include patients as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
Who may be able to join
- Cohort 1:
- Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease.
- Known to be pMMR/MSS or MMR/MS status unknown.
- Prior first-line systemic oxaliplatin - and fluorouracils-based therapy for metastatic disease progressed.
- Patients had not received IRI or Nal-IRI during the treatment phase of metastatic disease.
- Patients were scheduled to receive Nal-IRI plus fluorouracils or IRI plus fluorouracils chemotherapy regimens as second-line systemic therapy.
Show all 22Show fewer
- Cohort 2:
- Patients with histologically or cytopathologically confirmed colorectal adenocarcinoma who were diagnosed with unresectable metastatic disease;
- Known to be pMMR/MSS or MMR/MS status unknown.
- Patients had received ≤ 3 lines of previous treatment for metastatic disease.
- Progression of metastatic disease after treatment with an IRI-containing regimen (no limit on the number of IRI treatment lines).
- The patient had not previously received Nal-IRI and was scheduled to receive a systemic Nal-IRI containing chemotherapy regimen as palliative treatment.
- Have at least one measurable lesion according to RECIST v1.1.
- Cohort 3:
- High-risk (CRS score 3-5) synchronous liver metastatic colorectal adenocarcinoma with ≤5 liver metastases, confirmed by histopathology or cytopathology, and planned resection.
- Known to be pMMR/MSS or MMR/MS status unknown.
- The patient was scheduled to receive Nal-IRI+ oxaliplatin + fluorouracils chemotherapy regimen as neoadjuvant therapy.
- Cohort 4:
- Non pancreatic cancer and non colorectal cancer patients confirmed by histopathology and/or cytology.
- Have received at least one systemic treatment for unresectable diseases;
- Plan to receive a systemic treatment regimen containing Nal IRI;
- At least one measurable lesion (according to RECIST v1.1);
Who cannot join
- Cohort 1-4:
- Treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy.
- Allergy to irinotecan or liposomal irinotecan and its excipients is known.
- Female patients known to be pregnant or lactating.
- Other patients who were deemed by the investigator to be ineligible for enrollment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Lin Shen, MD, (86)10-88196561, shenlin@bjmu.edu.cn
Lin Shen, MD
About this study
Official title: A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
- Conditions
- Colorectal Cancer, Solid Tumor
- Being tested
- Irinotecan Liposome
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irinotecan LiposomeDrug
The experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail.
| Study group | Role | What they receive |
|---|---|---|
| Second-line treatment for colorectal cancer | Cohort 1 is a concurrent control design, including patients treated with irinotecan liposome (Nal-IRI) or irinotecan (IRI) plus fluorouracils as second-line treatment for metastatic colorectal cancer. Receives: Drug: Irinotecan Liposome | |
| Posterior line treatment of colorectal cancer | Cohort 2 is a Simon two-stage design, is planned to include patients who are treated with a NAL-IRI based combination regimen and have used IRI as a late-line treatment for metastatic colorectal cancer. Receives: Drug: Irinotecan Liposome | |
| Neoadjuvant therapy for colorectal cancer | Cohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer. Receives: Drug: Irinotecan Liposome | |
| Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment | Cohort 4 is a single-arm design and is planned to enroll patients who are treated with the NAL-IRI containing regimen as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. Receives: Drug: Irinotecan Liposome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
To investigate the safety with Nal-IRI and IRI.
Measured: Assessed except to 10 months.
Objective response rate (Cohort 2 and 4)
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
Measured: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
R0 resection rate (Cohort 3)
To assess surgical conversion rates in patients who could be surgically resected.
Measured: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
Secondary outcomes (7)
Objective response rate (Cohort 1)
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
Measured: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
Disease control rate (Cohort 1,2,4)
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete , partial or stable response (SD) assessed by RECIST v1.1.
Measured: From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.
Progression free survival (Cohort 1,2,4)
To investigate antitumor efficacy of study. From initial medication to the date of first documented progression or end of medication, whichever came first.
Measured: From initial medication to the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Overall survival (Cohort 1,2,4)
To investigate antitumor efficacy of Nal-IRI. From initial medication to the date of death from any cause.
Measured: From initial medication to the date of death from any cause. Assessed up to 42 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)
To assess the incidence and severity of adverse events in combination regimens.
Measured: Assessed except to 24 months.
Pathological complete response rate (Cohort 3)
To investigate the effect of Nal-IRI.
Measured: After treatment and surgery, assessed up to 6 months.
Event-free survival (Cohort 3)
To investigate the effect of Nal-IRI.
Measured: The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start15 Jul 2024 (estimated)
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 933 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443307
- Sponsor's protocol ID
- CSPC-DEY-CRC-K02
- Status last verified
- May 2024
- First submitted
- 15 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-cohort, National Multicenter Real-world Study to Evaluate the Efficacy and Safety of Liposome Irinotecan
- ClinicalTrials.gov ID
- NCT06443307
- Acronym / sponsor ID
- CSPC-DEY-CRC-K02
- Conditions
- Colorectal Cancer, Solid Tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 933 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 5 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a prospective, multicenter, real-world study. There are four cohorts. Cohorts 1-3 include second-line, posterior-line, and neoadjuvant colorectal cancer patients, respectively. Cohort 4 include patients with the exception of those with pancreatic and colorectal cancer. As this study is a real-world investigation, treatment procedures, visit schedules, and examinations will be based on the routine clinical practice of physicians. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Second-line treatment for colorectal cancer | – | Drug: Irinotecan LiposomeCohort 1 is a concurrent control design, including patients treated with irinotecan liposome (Nal-IRI) or irinotecan (IRI) plus fluorouracils as second-line treatment for metastatic colorectal cancer. |
| Posterior line treatment of colorectal cancer | – | Drug: Irinotecan LiposomeCohort 2 is a Simon two-stage design, is planned to include patients who are treated with a NAL-IRI based combination regimen and have used IRI as a late-line treatment for metastatic colorectal cancer. |
| Neoadjuvant therapy for colorectal cancer | – | Drug: Irinotecan LiposomeCohort 3 is a single-arm design and planned to enroll patients who received Nal-IRI+ oxaliplatin + fluorouracils as neoadjuvant chemotherapy for colorectal cancer. |
| Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment | – | Drug: Irinotecan LiposomeCohort 4 is a single-arm design and is planned to enroll patients who are treated with the NAL-IRI containing regimen as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study was a prospective, multicenter real-world study with four cohorts. Cohort 1 include patients as second-line treatment for metastatic colorectal cancer. Cohort 2 include patients as a late-line treatment for metastatic colorectal cancer. Cohort 3 include patients as neoadjuvant chemotherapy for colorectal cancer. Cohort 4 include patients as second-line or beyond treatment for nonpancreatic, noncolorectal cancers. Through the above cohort, the efficacy and safety of irinotecan liposome are comprehensively observed.
Key inclusion criteria (22 listed)
- Cohort 1:
- Cohort 2:
- Cohort 3:
- Cohort 4:
Key exclusion criteria (5 listed)
- Treatment with an immune checkpoint inhibitor (e.g., pembrolizumab, nivolumab) was planned during chemotherapy.
- Allergy to irinotecan or liposomal irinotecan and its excipients is known.
- Female patients known to be pregnant or lactating.
- Other patients who were deemed by the investigator to be ineligible for enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Irinotecan LiposomeThe experimental group will collect data from patients treated with Nal-IRI as the chemotherapy regimen. It is recommended to use according to the label, clinical practice shall prevail. | Drug | Neoadjuvant therapy for colorectal cancer, Patients with non-pancreatic and non-colorectal cancer received second-line or above treatment, Posterior line treatment of colorectal cancer, Second-line treatment for colorectal cancer |
Primary outcome
Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1)
Time frame: Assessed except to 10 months.
To investigate the safety with Nal-IRI and IRI.
Objective response rate (Cohort 2 and 4)
Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
To investigate antitumor efficacy of Nal-IRI, proportion of patients with complete (CR) or partial response (PR) assessed by RECIST v1.1.
R0 resection rate (Cohort 3)
Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
To assess surgical conversion rates in patients who could be surgically resected.
7 secondary outcomes
Objective response rate (Cohort 1)
Time frame: From initial medication to the date of first documented progression or end of medication. Assessed up to 6 months.
Disease control rate (Cohort 1,2,4)
Time frame: From initial medication to the date of first documented progression or end of medication.Assessed up to 6 months.
Progression free survival (Cohort 1,2,4)
Time frame: From initial medication to the date of first documented progression or date of death from any cause, whichever came first. Assessed up to 24 months.
Overall survival (Cohort 1,2,4)
Time frame: From initial medication to the date of death from any cause. Assessed up to 42 months.
Incidence of adverse events and severity of adverse events as assessed by CTCAE 5.0 (Cohort 1,2,3,4)
Time frame: Assessed except to 24 months.
Pathological complete response rate (Cohort 3)
Time frame: After treatment and surgery, assessed up to 6 months.
Event-free survival (Cohort 3)
Time frame: The time from enrollment to any event, including death, disease progression, or switch to a treatment, occurred first. Assessed up to 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Solid Tumor, run by Peking 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 22 inclusion and 5 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 5 Jun 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.
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 Lin Shen (01088196561, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of grade ≥3 adverse events assessed by CTCAE 5.0 (Cohort 1) (time frame: Assessed except to 10 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jun 2024.