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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Second Affiliated Hospital of Shandong First Medical University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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,

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: TAS-102 combined with bevacizumabExperimental treatment 1 intervention

Trial outcomes

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

Time frame
2 years

Secondary outcomes

1

Overall Survival

Time from randomization to death from any cause

Time frame
3 year
2

Objective Response Rate

It refers to the proportion of patients (mainly solid tumors) whose tumor has shrunk to a certain extent and remained there for a certain period of time, including Complete Response (CR) and Partial Response (PR)

Time frame
2 year
3

Quality of life score

Quantitative scoring system for patients' self-subjective self-assessment of current symptom tolerance

Time frame
3 year

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: