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TAS-102 and Bevacizumab as salvage line chemotherapy for colorectal cancer (SOAC1701)

SOAC1701 (SOAC1701)

7

The seven patients enrolled had a median age of 83 years (72-90) and a male:female ratio of 4:3.

Case enrollment from two centers was performed from August 2019 to August 2020. Patients with unresectable advanced recurrent colorectal cancer, defined as Vulnerable in the guidelines by PS and age, were included in the study. The study was conducted in seven patients, except one patient who died after obtaining consent but before starting chemotherapy. Due to insufficient patient enrollment, the decision was made to discontinue the study on November 1, 2021.

The incidence of adverse events due to study treatment was 100.0% in 6 patients, except for 1 patient who died before treatment. Grade 5 of NCI-CTCAE ve.4.0 was observed in 1 patient, who died of interstitial pneumonia. The incidence of Grade 3/4 was 4(66.7%). All Grades were neutropenia 4(66.7%), anemia 2(33.3%), diarrhea 2(33.3%), thrombocytopenia 2(33.3%), elevated creatinine 1(16.7%), interstitial pneumonia 1(16.7%).

The primary endpoint was progression-free survival, but since the required number of patients was not met, no analysis will be performed.

The patients were enrolled from August 2019 to August 2020 from two centers. TAS-102+Bevacizumab as 2nd line treatment for patients with unresectable colorectal cancer who were 1: 20-74 years old and PS2, 2: 75 years old or older and PS0 or 1, 3: 20 years old or older and refractory or intolerant to irinotecan and oxaliplatin. The decision was made to discontinue the study on November 1, 2021 due to insufficient number of enrolled patients.

Mar. 01, 2022

No

No

https://jrct.niph.go.jp/latest-detail/jRCTs031180382

Matsubara Hisahiro

Chiba University Hospital

1-8-1Inohana, chuo-ku, Chiba-shi, Chiba

matsuhm@faculty.chiba-u.jp

Maruyama Tetsuro

Chiba University Hospital

1-8-1Inohana, chuo-ku, Chiba-shi, Chiba

+81-43-226-2109

t.maruyama@chiba-u.jp

Complete

Mar. 20, 2018

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) patient with any of the fllowing
(1) patient who is 20 years or older, and considered to be intorelant to irinotecan or oxaliplatin.
(2) Patient who is 20 to 74 years old and with an ECOG Performance Status of 2
(3) Patient who is over 75 years old and with an ECOG Performance Status of 0 or 1
2) patient who has histologically or cytologically confirmed colorectal adenocarcinoma
3) patient who has unresectable primary tumor or with one or more unresectable metatatic tumor(s)
4) patient who has a treatment history of one or more regimens for metastatic colorectal cancer, and who is refractory or intolerant to them
5) patient who has at least one measurable lesion in imaging study
6) patient with ability to tolerate oral drug administration
7) patient who has adequate main organ functions in tests within 14 days before enrollment
(1) WBC >= 3500/mm3
(2) neutrophil count >=1,500/mm3
(3) platelet count >=75,000/mm3
(4) haemoglobin concentorarion >=9.0 g/dL
(5) AST, ALT <= 2.5x Upper limit of normal (<= 5.0x when liver metastasis exists)
(6) serum total bilirubin level <=1.5 mg/dL (<= 2.0 when liver metastasis exists)
(7) serum creatinine <=1.5 mg/dL
(8) no active infection
(9) Peripheral neuropathy<=grade2
(10) Diarrhea and NonHaematotoxicity =<grade1
8) gave written informed consent

1) contraindications for TAS-102 and BEvacizumab
2) previously received chemotherapy with TAS-102
3) severe drug allergy
4) pregnant woman or Possibility of the pregnant woman. male patient who hoping partner's pregnancy.
5) patient who has important clinical complications(symptomatic unstable ischemic heart disease, arrhythmia, acute myocardial infarction within 6 months, liver cirrhosis, renal failure, active gastrointestinal ulcer, ileus, uncontrolled diabetes, uncontrolled hypertension, etc.)
6) have pleural effusion and ascitic fluid with the treatment
7) previous hemoptysis (over 25ml of fresh blood)
8) current or previous (within the last 6 months) history of GI perforation
9) patient with thrombosis (within the last 6 months)
10) patient with bleeding tendency
11) synchronous or metachronous multiple malignancy within the last 5 year disease free interval
12) dicision of unsuitable for this study by the investigator

Both

Colorectal Cancer

Repeat administration until the following regimen falls into the 28 days as one course and falls under the criteria for discontinuation of study treatment.
TAS - 102 is administered for 2 consecutive days after a continuous oral administration for 5 days twice a day after dinner and meal, with the prescribed dosage adjusted to body surface area. Repeat this 2 times and then take a rest for 14 days. Repeat administration with this as a course. Incidentally, weight reduction is made according to the condition of the patient.
Infusing Bevacizumab intravenously over the course of 90 minutes on Day 1, Day 15.

Colorectal Cancer

Progression Free Survival

1)Overall Survival
2)Time to Treatment Failure
3)Response Rate
4)Disease control rate
5)Adverse events
6)Relation between RAS status and effectiveness of chemotherapy
7)Relation between location of tumor and effectiveness of chemotherapy
8)Relation between the timing when chemotherapy started and effectiveness of chemotherapy

+81-43-226-2616

Jan. 23, 2019

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