Regorafenib Plus Raltitrexed as Third-line Treatment in Advanced Colorectal Cancer Patients

NCT05426811 | Unknown Phase 1 DMC

• 1 other identifier: REGORAL
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a multicenter, open, single-arm, phase I/II study to evaluate the efficacy and safety of regorafenib plus raltitrexed as third-line treatment in patients with advanced colorectal cancer.

Conditions

Regorafenib; Raltitrexed; Colorectal Neoplasms; Third-line Treatment

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  PFS, defined as the time from randomization to the first occurrence of disease progression as determined by the investigator with use of RECIST v1.1 or death from any cause, whichever occurs first.

  one year

Secondary Outcomes (4)

• Objective Response Rate (ORR)

  one year

• Disease Control Rate (DCR)

  one year

• Overall Survival (OS)

  two years

• Incidence and severity of adverse events (AE) and serious adverse events (SAE)

  two years

Study Arms (1)

Regorafenib combined with Raltitrexed

EXPERIMENTAL

Regorafenib: 120mg/d，Po，qd,d1-d21，Every 4 weeks Raltitrexed: 3mg/㎡，ivgtt，d1，Every 3 weeks

Drug: Regorafenib; Drug: Raltitrexed

Interventions

Regorafenib DRUG

Regorafenib:120mg/d，Po，qd,d1-d21，Every 4 weeks

Also known as: Stivarga

Regorafenib combined with Raltitrexed

Raltitrexed DRUG

Raltitrexed:3mg/㎡，ivgtt，d1，Every 3 weeks

Also known as: Sai wei jian

Regorafenib combined with Raltitrexed

Eligibility Criteria

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

You may qualify if:

• Sign a consent form
• Age\> 18 years
• Pathological diagnosis as metastatic colorectal adenocarcinoma
• Metastatic colorectal cancer with disease progression after 1st and 2nd line treatment；Received standard chemotherapy based on fluorouracil, oxaliplatin, irinotecan, patients are allowed to receive EGFR and/or VEGF inhibitors, patients are allowed to receive immunotherapy.
• Measurable disease according to RECIST
• ECOG score 0-1 points
• Life expectancy ≥3 months
• ALT and AST\< 2.5 times the upper limit of normal (ULN), patients with liver metastases \< 5 times ULN
• Serum albumin ≥ 3.0g/ dL
• Serum ALP \<2.5 times ULN
• Total bilirubin \<l.5mg / dL
• Estimated creatinine clearance (CLcr) ≥30mL/min as calculated using the Cockcroft-Gault equation
• Lipase≤1.5x the ULN
• Neutrophil absolute count (ANC) ≥1500/mm³, hemoglobin (Hb)\>9g/dl, platelets\> 10000/mm³
• Pregnant or breastfeeding patients. (1) Women and men of childbearing potential must agree to use appropriate contraception prior to entering the program until at least 8 weeks after the last dose of study drug. The investigator or designee is required to advise the subject on how to achieve appropriate contraception. Adequate contraception is defined in the study as any medically recommended method (or combination of methods) according to standard treatment 2) Women of childbearing age must confirm a negative serum or urine pregnancy test within 7 days prior to initiating treatment and must agree to record a negative result prior to entering the study

You may not qualify if:

• Prior exposure to any VEGFR tyrosine kinase inhibitor (e.g., regorafenib, apatinib, anlotinib, furoquinitinib, etc.) therapy
• Received raltitrexed in the previous treatment
• Patients with abnormal coagulation function or those treated with thrombolytic or anticoagulant drugs with a tendency to bleed from the gastrointestinal tract, including active peptic ulcer with fecal occult blood ++, vomiting blood or black stool within 3 months
• Prior or concurrent cancers with a different primary site or histology than CRC within the enrollment year, except cured in situ cervical cancer, non-melanoma skin cancer, and superficial bladder tumors: staged Ta, Tis, and T1
• Arterial or venous thrombotic or embolic events such ascerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within 6 month before the start of study medication (except for adequately treated catheter-related venous thrombos is occurring more than one month before the start of study medication)
• Major surgery, biopsy or significant traumatic damage within 28 days prior to the start of investigational treatment
• Non-healing wound, non-healing ulcer, or non-healing bone fracture.
• Patients with brain metastases and/or cancerous meningitis
• Congestive heart failure \> New York Heart Association (NYHA) class 2.
• Unstable angina (angina symptoms at rest), new onset angina (occurred within the last 3 months). Myocardial infarction within 6 months prior to the start of treatment.
• Arrhythmias requiring antiarrhythmic therapy (beta-blockers or digoxin allowed)
• Uncontrolled hypertension. (Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg despite optimal medical treatment)
• Patients with pheochromocytoma
• Pleural effusion or ascites causing restricted breathing (≥ CTCAE grade 2 dyspnea)
• Known to have dihydropyrimidine dehydrogenase deficiency

Sponsors & Collaborators

• China Medical University, China: lead
• The People's Hospital of Liaoning Province: collaborator
• Anshan Tumor Hospital: collaborator
• The First Affiliated Hospital of Dalian Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Benxi Cental Hospital: collaborator

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib; raltitrexed

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yunpeng Liu, PhD

  First Hospital of China Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunpeng Liu, PhD

CONTACT

86-24-83282312; cmu_trial@163.com

Ling Xu, PhD

CONTACT

cmuxuling@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 22, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2025
• Study Completion: December 30, 2025
• Last Updated: June 29, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share