The Efficacy and Safety of TAS-102(Suyuan) Combined With Bevacizumab as First-line Therapy in Patients With Advanced Colorectal Cancer

NCT06092242 | Not Yet Recruiting Phase 2

• 1 other identifier: MT-006
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of TAS-102 combined with bevacizumab as first-line therapy in patients with advanced colorectal cancer who could not tolerate or did not receive combined chemotherapy

Conditions

Colorectal Cancer

Keywords

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival

  The length of time during and after the treatment of a disease, such as cancer, that a patient lives with the disease but it does not get worse

  2 years

Secondary Outcomes (3)

• Overall Survival

  3 year

• Objective Response Rate

  2 year

• Quality of life score

  3 year

Study Arms (1)

TAS-102 combined with bevacizumab

EXPERIMENTAL

Drug: Tas-102(Suyuan) combined with bevacizumab

Interventions

Tas-102(Suyuan) combined with bevacizumab DRUG

Tas-102: po 35 mg/m2, bid, d1-5, d8-12, Q4 wks; bevacizumab: intravenous drip 5 mg/kg, D1, D15, Q4 wks.

TAS-102 combined with bevacizumab

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Life expectancy of at least 3 months
• Definitive histological or cytological evidence of adenocarcinoma of the colon or rectum;
• Patients who had not previously received first-line chemotherapy or targeted therapy for metastatic colorectal cancer, or who had received adjuvant chemotherapy after radical resection and had relapsed 12 months after completion of adjuvant chemotherapy;
• Patients who can not or can not tolerate combination chemotherapy.
• ECOG performance status was PS ≤2;
• According to RECIST Version 1.1, at least 1 measurable metastatic lesion was present;
• Appropriate organ function according to laboratory test values obtained within 7 days prior to administration of the study drug on Day 1 of Cycle 1.
• A .The hemoglobin value was more than 90 g/L. B. The absolute neutrophil count was \> 1.500 MM3. C. Platelet count was \> GT; 100,000/mm (\> GT; 100 \* 10 ° L) . D. Total serum bilirubin was 1.5 x upper limit of normal (ULN) . E.Don't L-aspartic Acid aminotransferase (asgot) and endolaminic aminotransferase (Alt SGPT)≤2.5 x upper limit of normal (ULN) , and AST and ALT ≤5 x ULN if abnormal liver function is due to basal liver metastasis.
• F. Serum creatinine ≤1.5 x upper limit of normal (ULN) or creatinine clearance ≥50 ml/min;.
• G.Adequate coagulation: international standard ratio (INR) or prothrombin time (PT)≤1.5 times the upper limit of normal;. Urine or serum pregnancy tests were negative within 7 days of randomization.
• Women at risk of pregnancy must agree to use adequate contraception during the study until 6 months after the cessation of the study drug; Men had to agree to use adequate contraception during the study until six months after the study drug was discontinued.
• Willing and able to follow research protocols and visit plans.

You may not qualify if:

• \. The existence of serious diseases and serious medical conditions, this includes, but is not limited to, the following:
• the presence of other active malignancies at the same time, excluding those that have not been diagnosed for more than 5 years or are considered curable with adequate treatment,
• the known presence of brain or pial metastases,
• systemic active infection (ie, infection leading to body temperature ≥38 ° C-RRB- ,
• clinically significant intestinal obstruction, pulmonary fibrosis, renal failure, liver failure, or symptomatic cerebrovascular disease,
• uncontrolled diabetes;
• patients who have experienced any arterial thrombosis, embolism, or ischemic or hemorrhagic disease in the last 6 months and have not improved after appropriate treatment, such as unstable myocardial infarction, unstable angina, cerebrovascular accident after treatment,
• severe/unstable angina, NYHA Class III or IV symptomatic congestive heart failure,
• clinically significant gastrointestinal bleeding,
• known presence of human immunodeficiency virus (HIV) or acquired conventional immunodeficiency syndrome (AIDS)-related disease, or active hepatitis B or C,
• presence of psychiatric disorders that may increase the risk of participating in the study or taking research drugs, or that may interfere with the interpretation of the study results;
• patients with grade 2 or more hypertension before treatment who had not improved or were unstable with antihypertensive drugs,
• patients with nephrotic syndrome or with proteinuria ≥2 + or more before treatment who had not improved or were unstable after treatment, 13-RRB- patients with a history of gastrointestinal perforation in the last 6 months,
• patients with Hypertensive crisis hypertensive encephalopathy. 2.Any of the following treatments were performed within a specific time frame prior to study drug administration,
• ）major surgery (laparotomy, thoracotomy, and evisceration by laparoscopy) was performed within the previous 4 weeks. Switch surgery was not included) ; 2) had received extended-range radiotherapy within the previous 4 weeks or had received limited-range radiotherapy within the previous 2 weeks; 3) had received any investigational medication within the previous 4 weeks. 3. Neurotoxicity of CTCAE grade 2 or above that has not subsided as a result of adjuvant therapy, 4. A pregnant or lactating woman. 5. The researchers did not consider it appropriate to enter the study.

Sponsors & Collaborators

• The Second Affiliated Hospital of Shandong First Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Shandong First Medical University

Tai’an, Shandong, 271000, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Haiyan Liu

  The Second Affiliated Hospital of Shandong First Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Kong

CONTACT

13153882807; kongyingcoco@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2023
• First Posted: October 23, 2023
• Study Start: October 15, 2023
• Primary Completion: October 15, 2025
• Study Completion (Estimated): October 15, 2027
• Last Updated: October 23, 2023

Record last verified: 2023-10

Locations

CN (1)