Regorafenib Combined With TAS-102 Versus Regorafenib Monotherapy in Third or Later Line Therapy of mCRC

NCT05970705 | Recruiting Phase 2

• 1 other identifier: FDZL-REGOT
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the clinical benefit of regorafenib combined with TAS-102 compared with regorafenib monotherapy in patients with metastatic colorectal cancer who have failed at least two lines of treatment, to explore the rationality of this combination therapy strategy and to obtain relevant survival and safety data.

Conditions

Metastatic Colorectal Cancer

Keywords

metastatic colorectal cancer; regorafenib; TAS-102; Trifluridine/Tipiracil

Outcome Measures

Primary Outcomes (1)

• PFS

  progression free survival

  from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months

Secondary Outcomes (4)

• OS

  from the time signing of ICF until the date of death from any cause, assessed up to 36 months

• ORR

  the rate of patients with CR and PR, through study completion, an average of 1 year

• DCR

  the rate of patients with CR, PR and SD, through study completion, an average of 1 year

• DOR

  the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause, assessed up to 36 months

Other Outcomes (1)

• AE

  the adverse events rate and types of all enrolled patients, through study completion, an average of 1 year

Study Arms (2)

A: Regorafenib+TAS-102 combination therapy

EXPERIMENTAL

Regorafenib 80mg ,orally, once a day, d1-28, every 28 days, TAS-102，35mg/m2, orally，twice a day, d1-5 \& d15-19，every 28 days

Drug: Regorafenib; Drug: Trifluridine/Tipiracil

B：Regorafenib monotherapy

ACTIVE COMPARATOR

Regorafenib, 120mg orally, once a day, d1-21, every 28 days (If the patient's body surface area is less than 1.5m2, the starting dose of regorafenib is 80mg)

Drug: Regorafenib

Interventions

Regorafenib DRUG

this anti-angiogenesis targeting drug is one of the standard third-line treatment options for patients with metastatic colorectal cancer

Also known as: Stivaga

A: Regorafenib+TAS-102 combination therapy; B：Regorafenib monotherapy

Trifluridine/Tipiracil DRUG

this chemotherapeutic drug is also one of the standard third-line treatment options for patients with metastatic colorectal cancer

Also known as: TAS-102

A: Regorafenib+TAS-102 combination therapy

Eligibility Criteria

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

You may not qualify if:

• The subjects must meet all of the following criteria to be eligible for this study:
• Patients with histologically confirmed recurrent/metastatic colorectal adenocarcinoma.
• Patients who have failed at least one prior standard first- or second-line therapy, including fluoropyrimidine-based therapy, oxaliplatin, irinotecan, and bevacizumab. Treatment failure is defined as either radiographic evidence of disease progression or unacceptable toxicity during treatment or within three months following completion of therapy.
• (Note: a. each line of therapy should include at least one or more chemotherapy agents administered for at least one cycle; b. adjuvant/neoadjuvant therapy is allowed. If relapse or metastasis occurs during or within six months after completion of adjuvant/neoadjuvant therapy, it is considered a failure of first-line chemotherapy for progressive disease. c. For patients with RAS/RAF wild-type tumors, the use of an EGFR inhibitor is not required.)
• At least one measurable lesion, with the longest diameter ≥10 mm on spiral CT or ≥20 mm on conventional CT (RECIST 1.1 criteria).
• ECOG performance status of 0-2.
• Life expectancy of ≥12 weeks.
• Adequate bone marrow, hepatic, and renal function measured within the screening period prior to randomization: absolute neutrophil count (ANC) ≥1.5 × 109 /L, hemoglobin ≥ 8.0 g/dL, platelet count ≥ 75 × 109 /L, total bilirubin \<1.5 × ULN, ALT and AST \<2.5 × ULN (≤5 × ULN for patients with liver involvement), serum creatinine ≤1.5 × ULN, and creatinine clearance ≥50 mL/min.
• Women of childbearing potential must use effective contraception.
• Voluntarily participating in this study, signing the informed consent form, understanding the purpose of the study and the necessary procedures, and willing to participate in this study.
• Patients who meet any of the following criteria will be excluded from the study:
• Proteinuria ≥2+ on dipstick or 24-hour urinary protein ≥1.0 g/24 h.
• Abnormal coagulation function (PT\>16s, APTT\>43s, TT\>21s, Fbg\<2g/L), bleeding tendency, or receiving thrombolysis or anticoagulation therapy.
• Patients at risk of gastrointestinal bleeding, including those with active digestive ulcers and fecal occult blood (++) and those with histories of black stools or hematemesis within three months.
• Receiving systemic antitumor therapy, including chemotherapy, signal transduction inhibitors, or immune therapies, within three weeks prior to screening.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

regorafenib; trifluridine tipiracil drug combination

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 Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: controlled, randomized

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: August 1, 2023
• Study Start: July 1, 2023
• Primary Completion: July 4, 2025
• Study Completion (Estimated): July 4, 2026
• Last Updated: August 1, 2023

Record last verified: 2023-07

Locations

CN (1)