Neoplasms

Symptoms and General Pathology

All Conditions

Neoplasm Metastasis

Neoplasms, Second Primary

Yuan Xianglin, Professional

Zhao Ben, Master

Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer and explore some biomarkers that relate to target therapy.

1. Establish a clinical database of patients who are diagnosed with metastasis colorectal cancer in tongji hospital.
2. Build a biological specimen banks of metastasis colorectal cancer through collecting blood samples from those patients who have reached an agreement with us.
3. Through clinical observation and data statistics, conclude the clinical outcome of target therapy in metastasis colorectal cancer.
4. To extract DNA from the blood and explore some biomarkers that related to target therapy in metastasis colorectal cancer.

The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer

Huazhong University of Science and Technology

Professor, Chief physician

Digestive System Diseases

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Unresectable mCRC patients who respond to chemotherapy will receive surgical resection of primary tumor.

Unresectable mCRC patients who were respond to chemotherapy will continue with chemotherapy.

Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'

Surgical resection of primary tumor

Gong Chen, Prof.

Rong-Xin Zhang, M.D.

Yu-Hong Li, M.D.

Ling-Hneg Kong, M.D.

Zhi-qiang Wang, PhD.

Xiao-Jun Wu, M.D.

Zhi-Zhong Pan, M.D.

Yan-Hong Deng, M.D.

Hui Wang, M.D.

Meng Qiu, M.D.

Zhi-zhong Pan, Prof.

De-Sen Wan, Prof.

There is still no perfect treatment suggestion for patients with asymptomatic colorectal cancer with unresectable metastatic disease. Whether patients can benefit from palliative resection of primary tumor or not is still waiting for answer. The investigators hypothesis that asymptomatic metastatic colorectal cancer patients who respond to chemotherapy will benefit from primary tumor resection.

Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients

Palliative Resection of Asymptomatic Primary Tumor Following Effective Induction Chemotherapy in Colorectal Cancer Patients With Unresectable Distant Metastasis: a Multi-center, Prospective, Randomized Controlled Study

Sun Yat-sen University

Sun Yat-Sen University Cancer Center

Neoplastic Processes

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy could continue to receive oral capecitabine as maintenance therapy, capecitabine, 1000mg/m2 bid d1-14, every 3 week.

The maintenance treatment was continued until progression, unacceptable toxicity, or patient withdrawal.

maintenance with apecitabine，1,000 mg/m2 twice a day， days1-15，every 3 weeks，until progression, unacceptable toxicity, or patient withdrawal.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation

Observation

Ruihua Xu, M.D,Ph.D

Colorectal cancer is one of the most common malignant tumors, with the morbidity of approximate 100 million cases per year. About 40% of patients present with metastatic (stage IV) colorectal cancer at the time of diagnosis, and about 25% of patients with local lesion will ultimately develop metastatic disease.

5-Fluorouracil（5-FU) was the only efficacious treatment for metastatic colorectal cancer before the nineties of the 20th century, and afterwards as the discovery of chemotherapy such as oxaliplatin, irinotecan and capecitabine, response rate as well as survival had been improved greatly.

Most of advanced colorectal cancer will progress after first-line treatment; therefore, seeking an efficient and low toxic maintaining regimen to prolong PFS becomes a hot topic in oncologic field. Some clinical researches demonstrated that maintaining treatment followed first-line treating advanced NSCLC could extend PFS and OS. In metastatic colorectal cancer, patients receiving 5-FU/leucovorin(LV) maintaining therapy experienced significantly longer PFS than that stopped chemotherapy after six cycles of FOLFOX4 in OPTIMOX2 study. One phase II study shown that median PFS was 13.9 months, and median OS was 31 months in 30 patients receiving first-line treatment of six- month FOLFOX4 followed by UFT as maintaining treatment . A non-randomized small sample study conducted in department of medical oncology of Sun Yat-Sen University Cancer Center indicated that patients receiving first-line treatment of XELOX followed by capecitabine as maintaining therapy has significantly prolonged median TTP, comparing with the non-maintaining treatment patients,(14months vs. 9 month, respectively).

Above all, so far, there is no data to demonstrate that regular 4-6 month chemotherapy followed by maintaining treatment could prolong TTP and OS for advanced colorectal cancer. Capecitabine is effective for colorectal cancer, and was approved as palliative treatment for advanced colorectal cancer and adjuvant chemotherapy; in addition, with its relative less frequency of side effects and convenient oral administration, capecitabine as maintaining regimen could be prone to be accepted by patients. Therefore, our study is designed to investigate that capecitabine as maintaining treatment after first-line palliative chemotherapy could improve TTP and OS for patients with advanced colorectal cancer through a perspective randomized clinical study.

Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy were randomly assigned to one of two groups, to receive either capecitabine (2000 mg/m2 per day on days 1-14,Q3W) as maintenance therapy or observation. The treatment will continue until disease progression or unacceptable toxicity.

Maintenance Treatment With Capecitabine in Colorectal Cancer Patients

Maintenance Treatment With Capecitabine Versus Observation After First Line Chemotherapy in Patients With Metastatic Colorectal Cancer: a Randomized Phase II Study

defined as the interval between initial treatment and the first documentation of disease progression or death

measured from the initiation of chemotherapy to the date of the last follow-up or death

Overall tumor response: This is defined as the occurrence of either a confirmed complete (CR) or a partial (PR) best overall response as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.

Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.

Sun Yat-sen University cancer center

Tegafur

Fuquinitinib:5 mg once daily, 2 weeks on/1 week off,q3w; Tegafur Gimeracil Oteracil:BSA(body surface area)\< 1.2m2,40mg/m2,p.o,bid,2 weeks on/1 week off,q3w; 1.2m2 \< BSA （body surface area）\< 1.5m2,50mg/m2,p.o,bid,2 weeks on/1 week off,q3w;BSA（body surface area） \>1.5m2,60mg/m2,p.o,bid,2 weeks on/1 week off,q3w;

Fuquinitinib+Tegafur Gimeracil Oteracil

Yang xiaobing, PhD

Li xiaoyan

This is an Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer

An Open, Single-arm, Multicenter, Prospective Phase II Study of Fuquinitinib Combined With Tegafur Gimeracil Oteracil in the Third-line Treatment of Patients With Advanced Metastatic CRC

PFS is defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first. Responses are according to the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as assessed by investigator

Defined as percentage of participants achieving assessed complete response (CR) and partial response (PR) by the investigator according to the RECIST 1.1.

DCR was defined as the percentage of participants who have a confirmed complete response（CR） or partial response（PR） or stable disease（SD） per RECIST 1.1 as assessed by investigator

OS is the time from enrollment to death due to any cause.

overall incidence of adverse events (AE); incidence of grade 3 or higher AE; incidence of severe adverse events (SAE); incidence of AEs leading to discontinuation of drug use; incidence of AEs leading to suspension of drug use.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer	NCT02523495	Neoplasms, Ther...		-	Huazhong University of Science and Technology
The Clinical Outcome and the Exploration of Related Biomarkers of Target Therapy in Metastasis Colorectal Cancer	NCT02523495	Neoplasms, Ther...		-	Huazhong University of Science and Technology
Effectiveness Study of Resection of Primary Tumor in Stage IV Colorectal Cancer Patients	NCT02149784	Colorectal Canc...	Surgical resect...	18 Years - 75 Years	Sun Yat-sen University
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer	NCT06255379	Metastasis Colo... Colon Cancer Rectal Cancer	Fuquinitinib+Te...	18 Years - 75 Years	Guangzhou University of Traditional Chinese Medicine
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University
Study of Fruquintinib Combined With Tegafur Gimeracil Oteracil in Patients With Metastatic Colorectal Cancer	NCT06255379	Metastasis Colo... Colon Cancer Rectal Cancer	Fuquinitinib+Te...	18 Years - 75 Years	Guangzhou University of Traditional Chinese Medicine
Maintenance Treatment With Capecitabine in Colorectal Cancer Patients	NCT02027363	Colorectal Neop... Neoplasms Metas...	Capecitabine Observation	18 Years - 75 Years	Sun Yat-sen University

Spots Global Cancer Trial Database for metastasis colorectal cancer