Cholangiocarcinoma Clinical Trial
Official title:
A Phase II Trial of LDK378 as the First or Second-line Therapy in ROS1 and /or ALK Over-expressed Advanced Intrahepatic or Hilar Cholangiocarcinoma
Primary objective:
To investigate the objective response rate in patients with ROS1 or ALK over-expressed
locally advanced, or metastatic intrahepatic or hilar cholangiocarcinoma receiving LDK378
Secondary objectives:The progression-free survival ,The disease control rate ,The overall
survival ,The toxicity profiles , The correlation between clinical outcomes and the potential
predictive biomarker for tumor response
Sample size: LDK378 will be considered as an active agent and deserved for further
development. Considering 10% dropout rate, total 34 patients will be included.
Step 1: LDK378 in suitable patients:
Collect tumor tissue for immunohistochemistry staining to confirm the status of ROS1 or ALK
expression. If the patient fits all criteria, LDK378 750 mg ( p.o.) daily, with 3 week as a
treatment cycle.
Step 2: Evaluation of tumor response according to RECIST 1.1 version
1. Evaluation will be done at baseline and every 6 weeks
2. Evaluation will be performed with CT or MRI and the response is defined as follows:
- Complete response - the disappearance of all target lesions.
- Partial response - at least a 30% decrease in the sum of the longest diameter of
target lesions compared to the baseline sum longest diameter.
- Progressive disease - at least a 20% increase in the sum of the longest diameter of
target lesions compared to the smallest sum longest diameter recorded since the
treatment started or the appearance of one, or more new lesions, or reappearance of
any lesion that had disappeared, or clear worsening of any assessable disease, or
appearance of any new lesion or site.
- Stable disease - neither sufficient shrinkage to qualify for partial response nor
sufficient increase to qualify for progressive disease, compared to the smallest
sum longest diameter since the treatment started
;
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