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

Advanced Metastatic Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05160896
• Other study ID #: SALIRI-2021
• Status: Recruiting
• Phase: Phase 2
• Start date: November 12, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: June 2023
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Ying Yuan, Ph.D&MD
• Phone: 13858193601
• Email: yuanying1999[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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].

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old.

2. Life expectancy = 3 months.

3. Patients with unresectable advanced colorectal cancer confirmed by histology or cytology.

4. 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.

5. At least one measurable lesion by CT or MRI according to RECIST1.1 criteria.

6. ECOG 0 ~ 1.

7. The major organs were functioning normally, and the laboratory examination results within 1 week met the following conditions before enrollment: ?Absolute neutrophil count (ANC)=1.5×109/L ?Platelet count(PLT)=90.0 × 109/L ?Hemoglobin concentration(HB) =90g/L? Total bilirubin(TBI)=1.5×ULN ? Serum creatinine (Cr)=l.5×ULN ,Endogenous creatinine clearance >60ml/min(Cockcroft-Gault Formula )?Aspartate aminotransferase (AST), Alanine aminotransferase (ALT), Alkaline phosphatase(AP): =2.5 ×ULN (=5 ×ULN for metastases to liver).

8. 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.

9. Sign the informed consent voluntarily.

Exclusion Criteria:

1. Allergic to any research drug and its excipients.

2. There is a history of brain metastases, uncontrolled spinal cord compression, or cancerous meningitis, or newly discovered evidence of brain or Pia Mater Disease.

3. History of other malignancies, except cured Basal cell or squamous Cell Carcinoma of the skin and carcinoma in situ of the cervix.

4. Participate in another clinical trial within 30 days prior to admission and receive a research drug and any concomitant therapy containing a research drug.

5. 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.

6. Bowel obstruction or incomplete bowel obstruction, history of inflammatory bowel disease or extensive Colectomy, 50% or extensive small bowel resection with chronic diarrhea.

7. 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.

8. Other conditions that the researchers think should be ruled out.

Related Conditions & MeSH terms

• Advanced Metastatic Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Raltitrexed
Raltitrexed 2 mg/m² iv, 15min. day 1
• Irinotecan
Irinotecan 180 mg/m² iv, 30 - 90 min. day 1
• Bevacizumab
Bevacizumab 5 mg/kg, iv, day 1
• Cetuximab
cetuximab 500 mg/ m² , iv, day 1

Locations

Country	Name	City	State
China	the Second Affiliated Hospital of Medical College of Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ORR	(overall response rate) measured in percentage of all treated patients according to RECIST 1.1 criteria	24 months
Secondary	PFS	Progression Free Survival	24 months
Secondary	OS	Overall Survival	36 months
Secondary	DCR	Disease Control Rate	24 months
Secondary	QOL(Quality of Life)	EORTC-QLQ-C30 is a cancer-specific instrument	24 months
Secondary	AEs	the occurrence of adverse reactions	24 months