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Advanced Metastatic Colorectal CancerPhase 2NCT05160896

SALIRI Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer

A Phase 2 study testing Raltitrexed, Irinotecan and Bevacizumab in people with Advanced Metastatic Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 The sponsor has not verified this record for over two years, so it may be out of date.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
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Trial summary

The objective is to investigate the efficacy and safety of raltitrexed combined with Irinotecan (SALIRI) based regimen as first-line treatment for advanced metastatic colorectal cancer(mCRC). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Metastatic Colorectal Cancer
What is being tested?
Raltitrexed, Irinotecan and Bevacizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteChina
Study dates
12 Nov 2021to 30 Jun 2023
Phase
Phase 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old.
  • Life expectancy ≥ 3 months.
  • Patients with unresectable advanced colorectal cancer confirmed by histology or cytology.
  • Patients with initially treated metastatic colorectal cancer who were assessed to be unable to undergo radical surgery，or recurrence and metastasis more than 6 months after receiving radical surgery adjuvant chemotherapy, and the metastases can not be removed.
  • At least one measurable lesion by CT or MRI according to RECIST1.1 criteria.
  • ECOG 0 ~ 1.
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  • The major organs were functioning normally, and the laboratory examination results within 1 week met the following conditions before enrollment: ①Absolute neutrophil count (ANC)≥1.5×109/L ②Platelet count（PLT）≥90.0 × 109/L ③Hemoglobin concentration（HB） ≥90g/L④ Total bilirubin（TBI）≤1.5×ULN ⑤ Serum creatinine （Cr）≤l.5×ULN ，Endogenous creatinine clearance >60ml/min（Cockcroft-Gault Formula ）⑥Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase(AP): ≤2.5 ×ULN (≤5 ×ULN for metastases to liver).
  • Women of child-bearing age must undergo a pregnancy test within 7 days prior to enrollment and have a negative result, and are willing to use an appropriate method of contraception during the trial and within 6 months after the last trial drug is given. For men who agree to use an appropriate method of contraception during the trial and up to six months after the last administration of the trial drug.
  • Sign the informed consent voluntarily.

Who cannot join

  • Allergic to any research drug and its excipients.
  • There is a history of brain metastases, uncontrolled spinal cord compression, or cancerous meningitis, or newly discovered evidence of brain or Pia Mater Disease.
  • History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix.
  • Participate in another clinical trial within 30 days prior to admission and receive a research drug and any concomitant therapy containing a research drug.
  • Any of the following events occurred during the first 6 months in Group A: cerebrovascular accident (including stroke or transient ischemic attack) , myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, and congestive heart failure NYHA Grade III or IV, drug-treated or clinically significant Arrhythmia, prolonged Q-T interval of ECG, etc.
  • Bowel obstruction or incomplete bowel obstruction, history of inflammatory bowel disease or extensive Colectomy, 50% or extensive small bowel resection with chronic diarrhea.
  • The presence of an active infection or a concomitant disease that seriously endangers the patient's safety or affects the patient's ability to complete the study.
  • Other conditions that the researchers think should be ruled out.

Trial locations and contacts

1 site in 1 country.

Ying Yuan, Ph.D&MD contact

13858193601

yuanying1999@zju.edu.cn

China1 site, 1 recruiting

  • the Second Affiliated Hospital of Medical College of Zhejiang University

    Hangzhou, Zhejiang, 310000

    Ying Yuan, 13858193601, yuanying1999@zju.edu.cn

    Ying Yuan, Ph.D & MD

    Recruiting

Other trials in China

About this study

Official title: Raltitrexed Combined With Irinotecan (SALIRI) Based Regimen as First-line Treatment for Advanced Metastatic Colorectal Cancer (mCRC) : an Open-label, Multi-center, and Prospective Study

The objective is to investigate the efficacy and safety of raltitrexed combined with Irinotecan (SALIRI) based regimen as first-line treatment for advanced metastatic colorectal cancer(mCRC).

Read the detailed description

A number of previous studies show that raltitrexed combined with oxaliplatin/irinotecan as first-line treatment for advanced metastatic colorectal cancer(mCRC) is safe and effective. Chinese registered clinical studies show that raltitrexed combined with oxaliplatin has better safety and overall clinical efficacy than 5-FU combined with oxaliplatin in the treatment of mCRC. However, there is no study data on raltitrexed plus irinotecan (SALIRI) combined with targeted drugs as first-line treatment for mCRC in Chinese patients. This an open-label, multi-center, and prospective phase Ⅱ study enroled mCRC patients treated with first-line raltitrexed plus Irinotecan (SALIRI) based chemotherapy. Plan to to enroll 90 patients. The primary outcome is Overall Response Rate(ORR). The secondary Outcomes are Progression Free Survival (PFS)，Overall Survival (OS)，disease control rate (DCR)，the occurrence of adverse reactions(AEs)，and Quality of Life [WHO-QOL].

Being tested
Raltitrexed, Irinotecan, Bevacizumab, Cetuximab
Keywords
raltitrexed, irinotecan, first-line Treatment, Advanced Metastatic Colorectal Cancer

What participants receive

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

  • RaltitrexedDrug

    Also called Sai Wei Jian

    Raltitrexed 2 mg/m² iv, 15min. day 1

  • IrinotecanDrug

    Also called CPT-11

    Irinotecan 180 mg/m² iv, 30 - 90 min. day 1

  • BevacizumabDrug

    Also called Avastin

    Bevacizumab 5 mg/kg, iv, day 1

  • CetuximabDrug

    Also called ERBITUX

    cetuximab 500 mg/ m² , iv, day 1

Study groups in NCT05160896
Study groupRoleWhat they receive
MSS or MSI-L/pMMR, RAS and BRAF are both wild typeExperimentalthe primary lesion is located in the left colorectal: SALIRI plus cetuximab One cycle (cycle duration 14 days) consists of: Raltitrexed 2 mg/m² iv, 15min. day 1 Irinotecan 180 mg/m² iv, 30 - 90 min. day 1 cetuximab 500 mg/ m² , iv, day 1 the primary lesion is located in the right colorectal: SALIRI plus bevacizumab One cycle (cycle duration 14 days) consists of: Raltitrexed 2 mg/m² iv, 15min. day 1 Irinotecan 180 mg/m² iv, 30 - 90 min. day 1 Bevacizumab 5 mg/kg, iv, day 1
Receives: Drug: Raltitrexed; Drug: Irinotecan; Drug: Bevacizumab; Drug: Cetuximab

What is being measured

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

  1. ORR

    (overall response rate) measured in percentage of all treated patients according to RECIST 1.1 criteria

    Measured: 24 months

Secondary outcomes (5)

  1. PFS

    Progression Free Survival

    Measured: 24 months

  2. OS

    Overall Survival

    Measured: 36 months

  3. DCR

    Disease Control Rate

    Measured: 24 months

  4. QOL(Quality of Life)

    EORTC-QLQ-C30 is a cancer-specific instrument

    Measured: 24 months

  5. AEs

    the occurrence of adverse reactions

    Measured: 24 months

Timeline

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

  1. First posted16 Dec 2021
  2. Study start12 Nov 2021
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion30 Jun 2023 (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
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05160896
Sponsor's protocol ID
SALIRI-2021
Status last verified
Jun 2023
First submitted
6 Dec 2021
Last updated
8 Jun 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Raltitrexed, Irinotecan and Bevacizumab in people with Advanced Metastatic Colorectal Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 9 inclusion and 8 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 8 Jun 2023. 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?

Results are not available in the source record.

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

Contact Ying Yuan, Ph.D&MD (13858193601, yuanying1999@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 24 months). 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 NCT05160896.

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 8 Jun 2023.

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