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AzTrials

Colorectal CancerPhase 2NCT06405139

Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy of Locally Advanced Colorectal Cancer

A Phase 2 study testing Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Colorectal Cancer
What is being tested?
Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteChina
Study dates
1 May 2024to 30 Apr 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • With a full understanding of the study, each participant volunteered to participate in this study and signed the informed consent (ICF) with good compliance and follow-up.
  • Age ≥18 and ≤70.
  • ECOG physical status score is 0 or 1.
  • Expected survival period ≥ 12 weeks.
  • Patients with histopathological confirmed MSS/pMMR-type adenocarcinoma of the colon and upper rectum which is not amenable to radiotherapy.
  • R0 resection was expected to be achieved by necessarily combined organ resection, or R0 resection cannot be achieved, assessed by CT and/or MRI and multidisciplinary team (MDT) discussion.
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  • The clinical stage was cT4N1-2M0 or cT4bN0M0 according to AJCC 8th edition.
  • Patients with multiple primary colorectal cancer are eligible, if one of the primary tumors meets the inclusion criteria.
  • Patients with intestinal obstruction was relieved by colonic stenting or ostomy.
  • Patients had not received systematic therapy, such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
  • At least one evaluable lesion (according to RECIST v1.1 standard);
  • Adequate organ function according to the following laboratory test values:
  • Hemoglobin value ≥90g/L.
  • White blood cell count ≥3.5*109/L.
  • Absolute neutrophil count ≥1.5*109/L.
  • Platelet count ≥100*109/L.
  • Serum creatinine ≤ upper limit of normal (ULN) or creatinine clearance ≥60ml/min.
  • Total serum bilirubin ≤1.5 upper normal limit (ULN).
  • Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤2.5 upper limit of normal value (ULN).
  • Women with reproductive potential (< 2 years after the last menstrual period) and men use effective contraceptive methods until half a year after the last treatment.

Who cannot join

  • Patients who had shown hypersensitivity to the test drugs or other liposomal products.
  • Patients who have participated in other clinical trials in the past 4 weeks.
  • Previous or concurrent cancer diagnosed within 5 years (except cured basal cell carcinoma or squamous cell carcinoma of the skin and carcinoma in situ of the cervix; the treatment of other malignant tumors has been completed for more than 5 years, and there is no clinical and imaging evidence of recurrence or progression except).
  • dMMR/MSI-H-type colorectal cancer.
  • Symptomatic peripheral neuropathy ≥ grade 2 (CTCAE 5.0).
  • Patients unable to swallow or lack of physical integrity of the upper gastrointestinal tract, malabsorption syndrome, or inability to take oral medication.
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  • Patients had severe bleeding (CTCAE 5.0 grade ≥3) in the previous 4 weeks.
  • History of abdominal fistula, gastrointestinal perforation, intestinal obstruction, chronic diarrhea, or inflammatory bowel disease including Crohn's disease and ulcerative colitis within 6 months prior to the first study treatment.
  • Patients with interstitial lung disease, except only imaging demonstrated interstitial lung disease without symptoms.
  • Uncontrolled central nervous system metastasis (symptomatic or metastatic sites are midbrain, pons, medulla, or spinal cord) or other central nervous system diseases.
  • Received strong inhibitors or inducers of CYP3A4 and CYP2C8, or strong inhibitors of UGT1A1 in the previous 2 weeks.
  • Uncontrolled hypertension by a single-antihypertensive medication (systolic blood pressure >140 mmHg or diastolic pressure >90 mmHg). Patients with severe cardiac dysfunction, such as LVEF< 50%, CHF≥ grade 2, severe/unstable angina, history of stroke or transient ischemic attack or myocardial infarction in the previous 6 months. Patients with a history of ventricular tachycardia, torsades de pointes, prolonged QTc, complete left bundle branch block, or third-degree atrioventricular conduction block.
  • Abnormal blood coagulation function, bleeding tendency or receiving thrombolysis or anticoagulant therapy.
  • Patients of childbearing potential are unwilling to practice contraception.
  • Patients with active hepatitis B, hepatitis C, syphilis, or human immunodeficiency virus infection.
  • Patients with current active infections require anti-infection treatment within 2 weeks of starting study treatment.
  • History of a definite neurological or mental disorder, including epilepsy and dementia.
  • Patients with any clinically significant disease, metabolic disorders, or laboratory abnormality. The investigator could reasonably consider those patients not suitable for the study, affecting the analysis of the results or putting those patients at high risk.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lin Yang contact

13611267380

linyangcicams@126.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

    Lin Yang, +8613681015148, linyangcicams@126.com

    Recruiting

Other trials in China

About this study

Official title: Phase II Study of Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine As Conversion Therapy for Patients with Locally Advanced Colorectal Cancer

Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.

Read the detailed description

After patients are enrolled, they will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.

Being tested
Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine
Keywords
Locally Advanced Colorectal Cancer, Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine, Conversion Therapy
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Nanoliposomal Irinotecan, Oxaliplatin plus CapecitabineDrug

    Also called Nanoliposomal Irinotecan, Oxaliplatin, Capecitabine

    Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.

Study groups in NCT06405139
Study groupRoleWhat they receive
Nanoliposomal Irinotecan, Oxaliplatin plus CapecitabineExperimentalPatients will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.
Receives: Drug: Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

What is being measured

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

  1. Organ-sparing R0 Resection Rate

    The proportion of patients achieved R0 resection by only resecting the colon while other organs were retained.

    Measured: 2 years

Secondary outcomes (7)

  1. ypTNM stage

    ypTNM stage evaluated by pathologists

    Measured: 2 years

  2. TRG

    Tumor regression grade evaluated by pathologists

    Measured: 2 years

  3. R0, R1, R2 resection rate

    R0, R1, R2 Resection Rate

    Measured: 2 years

  4. Rate of residual or recurrent disease occurring within 2 years after surgery

    The proportion of patients who experienced residual or recurrent disease within 2 years after surgery.

    Measured: 2 years

  5. 3-year OS rate

    The proportion of patients achieved 3-year survival from treatment.

    Measured: 3 years

  6. 3-year PFS rate

    The proportion of patients did not progress at least 3 years from treatment.

    Measured: 3 years

  7. Safety and Tolerability

    Incidence of Treatment-Related Adverse Events

    Measured: 2 years

Timeline

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

  1. First posted8 May 2024
  2. Study start1 May 2024
  3. Primary completion30 Apr 2026 (estimated)
  4. Study completion30 Apr 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06405139
Sponsor's protocol ID
NCC4610
Status last verified
May 2024
First submitted
3 May 2024
Last updated
29 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine in people with Colorectal Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 20 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: looking for participants now, as of the sponsor's last update on 29 Nov 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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

Contact Lin Yang (13611267380, linyangcicams@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organ-sparing R0 Resection Rate (time frame: 2 years). 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 NCT06405139.

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 29 Nov 2024.

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