Clinical trial NCT03239015: Efficacy and Safety of Precision Therapy in Refractory Tumor
Official title: Efficacy and Safety of Precision Therapy in Refractory Tumor (Long March Pathway)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rare Tumor
Refractory Tumor
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2017-08-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is intended to evaluate efficacy and safety of targeted precision therapy in patients with refractory tumor, including rare tumor without standard recommended treatment and common tumor after multiple line of therapy.

Detailed description: The individuals recruited in the present study are with solid tumor, mainly including two parts: first, rare tumor without standard recommended treatment such as atypical fibrous histiocytoma; second, common tumor after multiple line of therapy such as lung cancer, gastric cancer, colorectal cancer, etc. All patients have no any standard therapy based on NCCN guideline when recruiting. Next-generation sequence was used to detect druggable molecular event including gene mutation, gene fusion, amplification, etc. Then patients with molecular events were treated with corresponding targeted drug and followed-up, and not limited tumor type. PD-1/L1 inhibior plus anti-angiogenic agent was used in patients without durgguable targets. The efficacy and safety of these regimens were evaluated.

Eligibility criteria: Inclusion Criteria:

* Malignant solid tumors diagnosed histologically;
* Common solid tumor patients have no any standard choice after multiple line of therapy; Rare solid tumor did not have any standard recommended treatment;
* Expected survival ≥ 1 month;
* ECOG / PS score: 0-2, and the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL \<1.5 times the upper limit of normal (ULN); Liver ALT and AST \<2.5 × ULN and if liver metastases, ALT and AST \<5 × ULN; Serum Cr ≤ 1 × ULN, endogenous creatinine clearance ≥50ml/min

Exclusion Criteria:

* Patient still has standard treatment therapy based on NCCN guidance;
* Patient can not comply with research program requirements or follow-up;

Primary outcomes:
measure: Objective Response Rate
timeFrame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 2 months
Secondary outcomes:
measure: Progress Free Survival
timeFrame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 2 months
measure: Overall Survival
timeFrame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 1 months
measure: Adverse Effect
timeFrame: Through study completion, an average of 1 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Yuan-Sheng Zang, MD.PHD
role: PRINCIPAL_INVESTIGATOR
References: