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

NCT05160896 | Unknown Phase 2

• 1 other identifier: SALIRI-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Advanced Metastatic Colorectal Cancer

Keywords

raltitrexed; irinotecan; first-line Treatment; Advanced Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• ORR

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

  24 months

Secondary Outcomes (5)

• PFS

  24 months

• OS

  36 months

• DCR

  24 months

• QOL(Quality of Life)

  24 months

• AEs

  24 months

Study Arms (1)

MSS or MSI-L/pMMR, RAS and BRAF are both wild type

EXPERIMENTAL

the 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

Drug: Raltitrexed; Drug: Irinotecan; Drug: Bevacizumab; Drug: Cetuximab

Interventions

Raltitrexed DRUG

Raltitrexed 2 mg/m² iv, 15min. day 1

Also known as: Sai Wei Jian

MSS or MSI-L/pMMR, RAS and BRAF are both wild type

Irinotecan DRUG

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

Also known as: CPT-11

MSS or MSI-L/pMMR, RAS and BRAF are both wild type

Bevacizumab DRUG

Bevacizumab 5 mg/kg, iv, day 1

Also known as: Avastin

MSS or MSI-L/pMMR, RAS and BRAF are both wild type

Cetuximab DRUG

cetuximab 500 mg/ m² , iv, day 1

Also known as: ERBITUX

MSS or MSI-L/pMMR, RAS and BRAF are both wild type

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

the Second Affiliated Hospital of Medical College of Zhejiang University

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Interventions

raltitrexed; Irinotecan; Bevacizumab; Cetuximab

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Ying Yuan, Ph.D&MD

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Yuan, Ph.D&MD

CONTACT

13858193601; yuanying1999@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2021
• First Posted: December 16, 2021
• Study Start: November 12, 2021
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: June 8, 2023

Record last verified: 2023-06

Locations

CN (1)