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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02403544
Other study ID # CH-GI-048
Secondary ID 13-102/778
Status Recruiting
Phase Phase 1
First received March 24, 2015
Last updated January 4, 2016
Start date September 2013
Est. completion date December 2016

Study information

Verified date January 2016
Source Chinese Academy of Medical Sciences
Contact Jing Jin, doctor
Phone 86-10-87787456
Email Jingjin1025@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial Summary

This is a phase I study to evaluate the safety of concurrent chemoradiation combining radiotherapy (IGRT) with two cytotoxic agents, capecitabine and oxaliplatin in patients with advanced or inoperable hepatocellular carcinoma.


Description:

In this phase I study, patients with advanced or inoperable hepatocellular carcinoma, or those failed other strategies will be recruited. The primary tumor and nearby metastatic nodes will be irradiated with Image-Guided Radiation Therapy (IGRT) mostly with conventional fractions. During the course, oral capecitabine and intravenous oxaliplatin will be given concurrently. The maximum tolerated dose (MTD) for the two drugs will be determined during escalation according to the occurrence of dose limiting toxicities (DLT).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 2016
Est. primary completion date June 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Criteria:

Inclusion Criteria:

- KPS=80.

- Life expectancy=16 months.

- Histopathologically or clinically diagnosed HCC.

- Barcelona-Clinic Liver Cancer (BCLC) 0-C without distant metastasis.

- The primary tumor is unresectable, inoperable or failed in other previous therapies.

- Child-pugh=6 (Child A), Indocyanine green retention rate at 15min <20%.

- HGb=100g/L, WBC=3×109/L, NEUT=1.5×109/L, PLT=75×109/L, Creatine=1.5mg/dl (UNL), Bun=30mg/dl, Alanine aminotransferase/Aspartate aminotransferase/Alkaline phosphatase=2.5×UNL, TBil=1.5×UNL, Prothrombin time=1.5×UNL, INR=1.5.

- No prior liver or upper abdomen radiation therapy.

- No previous history of allergic reaction attributed to fluorouracil or platinum drugs.

- Be conscious and could cooperate and comply with protocols for the study, such as simulation, smooth breathing and positioning for radiotherapy.

- Be ready to be followed up.

- Fulfill dosages requirement for targets and dose limits for organs at risk.

- The patient should be under anti-hepatitis-virus therapy if indicated.

- Sorafenib should be discontinued 7 days before the start of irradiation.

- Subjects informed of the diagnosis of advanced HCC who are fully informed about the content of the study by the investigator using the written consent form, and give written consent to participate in the study of their own free will.

Exclusion Criteria:

- KPS=70.

- Existing distant metastasis.

- Child-Pugh=7, Indocyanine green retention rate at 15min =20%.

- Primary tumor within the liver is not to be irradiated.

- Past liver transplantation.

- Complications of cirrhosis: active gastrointestinal bleeding, hepatic encephalopathy, refractory ascites, peritonitis, hepatorenal syndrome, hepatopulmonary syndrome.

- Upper gastrointestinal bleeding within 3 months.

- Any other carcinomas, except cured non-melanoma skin carcinoma, treated in-situ cervical cancer and =T1 bladder cancer.

- After planning optimization, the physician still consider risky to treat the patient with the plan or the benefit is negligible.

- Not conscious or can not cooperate or comply with the protocol for the study.

- Previous history of allergic reaction attributed to fluorouracil or platinum.

- Patients with serious comorbidities or uncontrolled medical conditions that the investigator feels might compromise study participation (including but not limited to: myocardial infarction, congestive heart failure (NYHA>2), unstable angina, active cardiomyopathy, unstable ventricular arrhythmia, uncontrolled psychotic disorders, uncontrolled hypertension and cerebrovascular disease with previous stroke within 6 months, serious infections,positive HIV test, poorly controlled diabetes mellitus with fasting blood-glucose >8mmol/L or 2-hour postprandial blood glucose >11mmol/L within the past month).

- Thrombolytic therapy within 4 weeks, or any concurrent anti-coagulant therapy.

- Pregnant, nursing, or possibly pregnant women, or women desiring to become pregnant during the study period.

- Participation in any investigational study within 4 weeks preceding the start of study treatment.

- Other cases judged by the investigator to be ineligible for participation in the study.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Radiation:
IGRT
IGRT: 45 to 54Gy, 1.8-3Gy per fraction.
Drug:
Capecitabine
Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.
Oxaliplatin
Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.

Locations

Country Name City State
China Cancer Hospital, Chinese Academy of Medical Sciences Beijing Beijing

Sponsors (3)

Lead Sponsor Collaborator
Chinese Academy of Medical Sciences Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd, Sanofi

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin up to four weeks after the end of the treatment. Yes
Secondary Dose Limiting Toxicity (DLT) up to four weeks after the end of the treatment. Yes
Secondary In field recurrence rate (LR) or local failure free survival (LFFS) From the completion of CCRT to 6, 12, 24, 36 months afterward. No
Secondary Intrahepatic failure rate or intrahepatic failure free survival (IHFFS) From the completion of CCRT to 6, 12, 24, 36 months afterward. No
Secondary Extrahepatic failure rate or extrahepatic failure free survival (EHFFS) From the completion of CCRT to 6, 12, 24, 36 months afterward. No
Secondary Overall survival From the completion of CCRT to 6, 12, 24, 36 months afterward. No
Secondary Tumor response rate including complete response and partial response rates 1 month and 3 month from the end of CCRT No
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