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mXELOXIRI Combined With Molecular Targeted Drug in mCRC | Clinical Trials | Clareo Health

UNKNOWNPHASE2

mXELOXIRI Combined With Molecular Targeted Drug in mCRC

mXELOXIRI Combined With Molecular Targeted Drug as First-line Therapy in Patients With Initially Unresectable Metastatic Colorectal Cancer: A Phase II, Single-arm, Prospective Clinical Study

NCT04160416•First Affiliated Hospital of Zhejiang University

View on ClinicalTrials.gov

Summary

The objective is to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy in patients with metastatic colorectal cancer (mCRC)

Detailed Description

It is an investigator-initiated, single institution, prospective, single-arm clinical study to evaluate the efficacy and safety of modified XELOXIRI combined with molecular targeted drug as first-line therapy in patients with unresectable mCRC. Eligible patients will receive 8 cycles of mXELOXIRI with cetuximab or bevacizumab and then the maintenance therapy until disease progression (PD) or unacceptable toxicity, whichever occurs first. Study evaluation time is defined as up to 16 weeks after the first dosing of the last patient.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Personal written informed consent is obtained after the study has been fully explained
•2. Histologically confirmed colon or rectal adenocarcinoma
•\*Excluding appendix cancer and anal canal cancer
•3. Clinically unresectable
•4. Borderline resectable liver metastases of colorectal cancer considered to have poor-risk disease not deemed to be suitable for upfront resection if they had one or more of the following features assessed by a local multidisciplinary team: more than four metastases, location and distribution of metastatic disease within the liver unsuitable for resection with clear margins (e.g. involvement of both lobes of liver, invasion of intrahepatic vascular structures), extent of liver involvement precluding resection with adequate post-resection residual liver parenchyma volume for viable liver function in the immediate postoperative period, and inability to retain adequate vascular inflow and outflow to maintain viable liver function.
•5. Age at enrollment is \>= 20 and \<= 75 years
•6. Life expectancy of at least 12 weeks.
•7. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 1
•8. Vital organ functions meet the following criteria within 14 days before enrollment.
•If multiple test results are available in that period, the results closest to enrollment will be used. No blood transfusions or hematopoietic factor administration will be permitted within 2 weeks before the date on which measurements are taken.
+2 more criteria

Exclusion Criteria

•1. Previous chemotherapy for other malignancies
•2. Clinically resectable
•3. Major surgical procedure within 28 days prior to study treatment initiation (such as open chest, laparoscopy, thoracoscopic surgery, laparoscopic surgery), unless only colostomy is performed; open biopsy or suturing for major trauma within 14 days of study treatment initiation; or planned major surgical procedure during the study (open chest, laparoscopy) ("major surgical procedures" does not include central venous (CV) port insertion)
•4. Have received any experimental therapy (such as take part in another clinical study) within 4 weeks before treatment;
•5. Receiving immunotherapy, chemotherapy, radiotherapy (except palliative radiotherapy), or hormonotherapy, which are not included in study protocol;
•6. Untreated brain metastases, spinal cord compression, or primary brain tumor;
•7. Pregnant, breastfeeding, positive pregnancy test (women who have menstruated in the last year will be tested), or women who are unwilling to use contraception; men who are unwilling to use contraception during the study
•8. Any of the following comorbidities i. Uncontrolled hypertension ii. Uncontrolled diabetes mellitus iii. Uncontrolled diarrhea iv. Peripheral sensory neuropathy (≥Grade 1) v. Active peptic ulcer vi. Unhealed wound (except for suturing associated with implanted port placement) vii. Other clinically significant disease (such as interstitial pneumonia or renal impairment)
•9. Subjects with known allergy to the study drugs or to any of its excipients.
•10. Any indication of contraindications to chemotherapy;
+5 more criteria

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Key Dates

Start Date

July 1, 2019

Primary Completion Date

November 1, 2020

Completion Date

January 1, 2022

Last Updated

November 19, 2019

Enrollment

ESTIMATED participants

Conditions

Unresectable Metastatic Colorectal Cancer

Interventions

Capecitabine-Oxaliplatin-Irinotecan Combination

DRUG

Contacts

Jiang F Weiqin, M.D

CONTACT

+86 15068117618 1312028@zju.edu.cn

He F Yinjun, Master

CONTACT

+86 18867139782 3150103327@zju.edu.cn

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UNKNOWNPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 19, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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