Carcinoma, HepatocellularPhase 1NCT02403544
Phase I Study of Image-Guided Radiation Concurrent With Double-Agent Chemotherapy for Hepatocellular Carcinoma
A Phase 1 study testing IGRT, Capecitabine and Oxaliplatin in people with Carcinoma, Hepatocellular, run by Chinese Academy of Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carcinoma, Hepatocellular
- What is being tested?
- IGRT, Capecitabine and Oxaliplatin
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Dec 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
About this study
Official title: Image-Guided Radiation Therapy (IGRT) Associated With Concurrent Capecitabine and Oxaliplatin in the Treatment of Locally Advanced or Inoperable Hepatocellular Carcinoma (HCC): A Phase I Study
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.
Read the detailed 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).
- Conditions
- Carcinoma, Hepatocellular
- Being tested
- IGRT, Capecitabine, Oxaliplatin
- Keywords
- Clinical Trial, Phase I, Concurrent Chemoradiation, Oxaliplatin, Capecitabine, Carcinoma, Hepatocellular
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGRTRadiation
Also called Image-guided radiation therapy
IGRT: 45 to 54Gy, 1.8-3Gy per fraction.
CapecitabineDrug
Also called CCRT concurrent chemotherapy 1 capecitabine
Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.
OxaliplatinDrug
Also called CCRT concurrent chemotherapy 2 oxaliplatin
Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.
| Study group | Role | What they receive |
|---|---|---|
| CCRT Arm | Experimental | Patients recruited will be treated by concurrent chemoradiotherapy with IGRT and two cytotoxic agents: capecitabine and oxaliplatin. Capecitabine will be taken orally twice a day, from D1 to D14 while oxaliplatin will be given intravenously on D1 and D8, every 21 days. The doses of the two drugs will be escalated alternatively in each level group. The radiation will be given by IGRT and the dose is between 45 to 54Gy, 1.8-3Gy per fraction. Receives: Radiation: IGRT; Drug: Capecitabine; Drug: Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin
Measured: up to four weeks after the end of the treatment.
Secondary outcomes (6)
Dose Limiting Toxicity (DLT)
Measured: up to four weeks after the end of the treatment.
In field recurrence rate (LR) or local failure free survival (LFFS)
Measured: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Intrahepatic failure rate or intrahepatic failure free survival (IHFFS)
Measured: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Extrahepatic failure rate or extrahepatic failure free survival (EHFFS)
Measured: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Overall survival
Measured: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Tumor response rate including complete response and partial response rates
Measured: 1 month and 3 month from the end of CCRT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sanofi
- Responsible party
- Principal investigator, Jing Jin, M.D., Chinese Academy of Medical Sciences
- Investigators
- Jing Jin, doctor, Study director, Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403544
- Sponsor's protocol ID
- CH-GI-048
- Other IDs
- 13-102/778
- Status last verified
- Jan 2016
- First submitted
- 24 Mar 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Guided Radiation Therapy (IGRT) Associated With Concurrent Capecitabine and Oxaliplatin in the Treatment of Locally Advanced or Inoperable Hepatocellular Carcinoma (HCC): A Phase I Study
- ClinicalTrials.gov ID
- NCT02403544
- Acronym / sponsor ID
- CH-GI-048
- Conditions
- Carcinoma, Hepatocellular
- Keywords
- Clinical Trial, Phase I, Concurrent Chemoradiation, Oxaliplatin, Capecitabine, Carcinoma, Hepatocellular
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical SciencesUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Sanofi
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CCRT Arm | Experimental | Radiation: IGRT, Drug: Capecitabine, Drug: OxaliplatinPatients recruited will be treated by concurrent chemoradiotherapy with IGRT and two cytotoxic agents: capecitabine and oxaliplatin. Capecitabine will be taken orally twice a day, from D1 to D14 while oxaliplatin will be given intravenously on D1 and D8, every 21 days. The doses of the two drugs will be escalated alternatively in each level group. The radiation will be given by IGRT and the dose is between 45 to 54Gy, 1.8-3Gy per fraction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGRTAlso: Image-guided radiation therapyIGRT: 45 to 54Gy, 1.8-3Gy per fraction. | Radiation | CCRT Arm |
| CapecitabineAlso: CCRT concurrent chemotherapy 1 capecitabineCapecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level. | Drug | CCRT Arm |
| OxaliplatinAlso: CCRT concurrent chemotherapy 2 oxaliplatinOxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level. | Drug | CCRT Arm |
Primary outcome
Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin
Time frame: up to four weeks after the end of the treatment.
6 secondary outcomes
Dose Limiting Toxicity (DLT)
Time frame: up to four weeks after the end of the treatment.
In field recurrence rate (LR) or local failure free survival (LFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Intrahepatic failure rate or intrahepatic failure free survival (IHFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Extrahepatic failure rate or extrahepatic failure free survival (EHFFS)
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Overall survival
Time frame: From the completion of CCRT to 6, 12, 24, 36 months afterward.
Tumor response rate including complete response and partial response rates
Time frame: 1 month and 3 month from the end of CCRT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Jin, doctor study director
Department of Radiation Oncology, Cancer Hospital, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IGRT, Capecitabine and Oxaliplatin in people with Carcinoma, Hepatocellular, run by Chinese Academy of Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Jin, doctor (86-10-87787456, Jingjin1025@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) for capecitabine and oxaliplatin (time frame: up to four weeks after the end of the treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2016; AzTrials last refreshed its copy on 30 Oct 2026.