TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer

NCT05993702 | Unknown DMC

• 1 other identifier: PRAY
• Study Type: observational
• Target: 45
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-arm, multicentre real-world observational study of TAS-102 in combination with regorafenib or fruquintinib for third-line and above advanced colorectal cancer.

Conditions

TAS 102; Regorafenib; Fruquintinib; Gastrointestinal Tumours

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 (3)

• Objective Response Rate (ORR)

  one year

• Disease Control Rate (DCR)

  one year

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

  two years

Study Arms (2)

TAS-102 in combination with regorafenib

(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle)

Drug: regorafenib

TAS-102 in combination with fruquintinib

TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle.

Drug: fruquintinib

Interventions

regorafenib DRUG

(TAS102): Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; (TKI: regorafenib: regorafenib capsules administered at a dose of 80 mg (2 tablets, each containing 40 mg regorafenib) once daily for a 28-day cycle)

Also known as: baiwange

TAS-102 in combination with regorafenib

fruquintinib DRUG

TAS102: Trifluridine tepipiridine tablets 35 mg/m2 twice a day, D1-5, D15-D19, 28 days as a cycle; or Fruquintinib: a dose of 3mg/dose administered orally once daily, continuously for 28 days as a cycle.

Also known as: elunate

TAS-102 in combination with fruquintinib

Eligibility Criteria

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

Study Population

Male or female patients between the ages of 18-75 years

You may qualify if:

• Male or female patients between the ages of 18-75 years;
• Patients with colorectal cancer diagnosed by histology or cytology;
• Patients with metastatic colorectal cancer who have failed two or more standard therapies; patients are permitted to have received prior chemotherapy with fluorouracil, oxaliplatin, irinotecan, and other regimens, patients are permitted to receive EGFR and/or VEGF inhibitors, and patients are permitted to have received prior immunotherapy;
• Have at least one measurable lesion according to the solid tumour efficacy evaluation criteria RECIST version 1.1; the measurable lesion should not have received local treatment such as radiotherapy (lesions located within the area of previous radiotherapy may also be selected as target lesions if progression is confirmed to have occurred and meets the RECIST 1.1 criteria);
• ECOG PS score: 0 to 1; expected survival more than 3 months;
• Oral medication is available;
• have adequate organ and bone marrow function, i.e., meet the following criteria:
• (1) Criteria for routine blood tests need to be met: Haemoglobin level (HB) ≥ 90 g/L (no transfusion within 28 days); Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelet count (PLT) ≥ 100×109/L. (2) Biochemical tests need to meet the following criteria: Serum total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN) ; ALT and AST ≤ 2.5 ULN (ALT and AST ≤ 5 ULN if liver metastases are present); Cr ≤ 1.5 ULN or creatinine clearance (CCr) ≥ 60 ml/min; (Cockcroft-Gault formula) (3) Adequate coagulation function, defined as International Normalised Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 times ULN; 8) Pregnant or breastfeeding patients: 1) Females and males of childbearing potential must agree to use adequate contraception prior to entering the programme until at least 8 weeks after the last dose of study drug. The Investigator or designee is required to advise subjects on how to achieve adequate contraception. Appropriate contraception is defined in the study as any medically recommended method (or combination of methods) based on standard treatment 2) Women of childbearing age must have a negative serum or urine pregnancy test confirmed 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:

• \- study:
• Patients with abnormal coagulation or a tendency to gastrointestinal bleeding on thrombolytic or anticoagulant medication, including active peptic ulcers with fecal occult blood++, vomiting blood or black stools within 3 months.
• Prior or concurrent cancers with a primary site or histology different from CRC within the year of enrolment, with the exception of cured in situ cervical cancer, non-melanoma skin cancers, and superficial bladder tumours:staging Ta, Tis and T1 .
• Arterial or venous thrombotic or embolic events, such as cerebrovascular accidents (including transient ischaemic attacks), deep vein thrombosis, or pulmonary embolism (except for appropriately treated catheter-associated venous thrombosis occurring more than 1 month after initiation of therapy), have occurred within 6 months prior to the start of treatment.
• Major surgery, biopsy or significant traumatic injury within 28 days prior to the start of investigational therapy.
• Unhealed wounds, ulcers, or fractures.
• Patients with brain metastases and/or carcinomatous meningitis.
• Congestive heart failure \>New York Heart Association (NYHA) class 2.
• Unstable angina (angina at rest), new onset angina (within the last 3 months). Myocardial infarction within 6 months prior to the start of treatment.
• Arrhythmia requiring antiarrhythmic therapy (beta-blockers or digoxin permitted). Uncontrolled hypertension. (Systolic blood pressure \> 150 mmHg or diastolic blood pressure \> 90 mmHg despite optimal medical therapy).
• Patients with pheochromocytoma
• Pleural effusion or ascites causing respiratory restriction (≥ CTCAE grade 2 dyspnoea)
• Active infection \>NCI CTCAE2 level
• interstitial lung disease with signs and symptoms at the time of informed consent
• known hypersensitivity to any of the drugs in the study, to drugs of the same class as the study drug, or to excipients in dosage forms

Sponsors & Collaborators

• China Medical University, China: lead

MeSH Terms

Interventions

regorafenib; HMPL-013

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: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Medical Oncology

Study Record Dates

• First Submitted: August 7, 2023
• First Posted: August 15, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share