Safety of Cetuximab and Trifluridin Tipiracil as the Third-line Therapy in the RASwt mCRC

NCT05155124 | Unknown Phase 1

• 1 other identifier: CT001
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-arm, prospective study to investigate the safety of cetuximab in combination with trifluridin tipiracil (TAS-102) in the third-line treatment of Chinese patients with RAS wild-type mCRC.

Conditions

Colorectal Neoplasms Malignant

Outcome Measures

Primary Outcomes (1)

• Incidence of DLT（Dose-limited toxicity）

  Determination of RP2D based on incidence of DLT

  From Baseline to primary completion date, about 18 months

Secondary Outcomes (1)

• Adverse Eevents

  From Baseline to primary completion date, about 18 months

Study Arms (1)

Cetuximab and trifluridin tipiracil

EXPERIMENTAL

Cetuximab will be administered at a fixed dose of 500 mg/m2 once every 2 weeks; trifluridin tipiracil will be administered in a dose de-escalation design: dose level 1: 35 mg/m2 twice daily on days 1-5 once every 2 weeks; Or dose level 0: 30 mg/m2, twice daily, Days 1-5, once every 2 weeks;

Drug: Cetuximab + trifluridin tipiracil

Interventions

Cetuximab + trifluridin tipiracil DRUG

Cetuximab will be administered at a fixed dose of 500 mg/m2 once every 2 weeks; trifluridin tipiracil will be administered in a dose de-escalation design: dose level 1: 35 mg/m2 twice daily on days 1-5 once every 2 weeks; Or dose level 0: 30 mg/m2, twice daily, Days 1-5, once every 2 weeks;

Also known as: Erbitux；TAS102;TAS-102

Cetuximab and trifluridin tipiracil

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 male or female;
• Histologically or cytologically confirmed metastatic colon or rectal adenocarcinoma; excluding appendiceal cancer and anal canal cancer;
• Previously received second-line treatment, at least 2 standard chemotherapy regimens(including fluorouracil, capecitabine, irinotecan, oxaliplatin, raltitrexed and anti-VEGF, anti-EGFR, etc.), if already accepted anti-EGFR treatment achieved at least PR or above;
• ECOG PS 0-1;
• At least one measurable lesion by CT or MRI (according to RECIST 1.1 criteria, the longest diameter of tumor lesion CT/MRI scan ≥ 10 mm, lymph node lesion CT/MRI scan shortest diameter ≥ 15 mm);
• RAS gene mutation detection results are wild-type. The test sample can be the primary tumor or metastasis sample;
• Can receive oral drug treatment;
• Normal function of major organs, meeting the following criteria within 14 days before the start of treatment:
• neutrophil count ≥ 1.5 × 10\*9/L;
• Platelet count ≥ 75 × 10\*9/L;
• Hemoglobin ≥ 9.0 g/dL;
• AST ≤ 2.5 × UNL (upper limit of normal) (if liver metastasis AST ≤ 5 × UNL);
• ALT ≤ 2.5 × UNL (if liver metastasis AST ≤ 5 × UNL);
• g.Creatinine clearance (calculated according to Cockcroft and Gault formula) \> 60 mL/min or serum creatinine ≤ 1.5 × UNL;
• Expected survival time \> 3 months (90 days);

You may not qualify if:

• Previously treated with regorafenib, fruquintinib, TAS-102;
• Participated in another drug clinical trial in the past 4 weeks, or received systemic chemotherapy, radiotherapy or biological therapy in the past 4 weeks;
• Known brain metastases or strongly suspected brain metastases;
• Patients with known BARF mutations should be excluded;
• Synchronous cancer or metachronous cancer with disease-free survival ≥ 5 years (except colorectal cancer), excluding mucosal cancer (esophageal cancer, gastric cancer, cervical cancer, non-melanoma skin cancer, bladder cancer, etc.) that has been cured or may be cured by local resection;
• Factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea and gastric intestinal obstruction; ucontrolled Crohn's disease or ulcerative colitis;
• Serosal effusion (including pleural effusion, ascites, pericardial effusion) with clinical symptoms and requiring symptomatic treatment;
• Pregnant or lactating women; patients of childbearing potential are unwilling or unable to take effective contraceptive measures;
• Known to be allergic to the study drug, study drug class and its ingredients;
• Conditions requiring systemic steroid treatment (except topical steroid and cetuximab pretreatment);
• History of interstitial lung disease (interstitial pneumonia, pulmonary fibrosis, etc.) or CT findings of interstitial lung disease;
• Active local or systemic infection requiring treatment;
• Cardiac function classification (NYHA classification) ≥ Grade III or severe heart disease;
• Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) or active hepatitis B, C;
• Toxicity not recovered (CTCAE \> grade 1) or not completely recovered from previous anticancer surgery;

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Hongli Liu

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongli Liu, PhD

CONTACT

+86-027-85871962; hongli_liu@hust.edu.cn

Jieying Zhang, MD

CONTACT

+86-027-85871962; whxhzjy@hust.edu.cn

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, Head of GI Department , Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: December 13, 2021
• Study Start: September 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: April 1, 2023
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)