Skip to content

Prospective, single-arm, single center, exploratory clinical study of Apatinib combined with Docetaxel as second line treatment in patients with advanced non-small cell lung cancer

Prospective, single-arm, single center, exploratory clinical study of Apatinib combined with Docetaxel as second line treatment in patients with advanced non-small cell lung cancer

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17013277
Enrollment
Unknown
Registered
2017-11-07
Start date
2017-11-15
Completion date
Unknown
Last updated
2017-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer

Interventions

Sponsors

Shanxi Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. aged 18-75 years male and female; 2. non-small lung cancer confirmed by pathology with measurable lesions; 3. First line treatment failure; 4. At least one imaging examination of measurable lesions (RECIST), CT or MR scan Long diameter of tumor = 10 mm; 5. ECOG 0-2; 6. Estimated survival time=3 mouths; 7. The main organ function is normal, and meet the following standards:(1)The standard of blood routine examination should be consistent: HB=90 g/L, ANC=1.5×10^9/L, PLT=80×10^9/L; (2)Biochemical tests should meet the following criteria: TBIL<1.5'ULN, ALT and AST<2.5'ULN, and < 5'ULN for liver metastasis patients; 8.After the operation, the wound healed completely without bleeding tendency; 9 . Fertile woman must perform a pregnancy test (serum or urine) 7 days before screened, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib. For man, surgical sterilization should be performed, or voluntarily adopt proper methods of contraception during the observation period and 8 week after the last given apatinib; 10 .Patients voluntarily entered the study and signed informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1. High blood pressure and failure to be reduced to normal range by antihypertensive drugs(Systolic pressure > 140 mmHg, diastolic pressure >90mmHg);Suffering from coronary heart disease, arrhythmia or grade II (including QTc prolongation > 450 ms male, female, 470 MS) and Cardiac insufficiency; 2. There are a variety of factors that affect oral medications (such as inability to swallow, chronic diarrhea, and intestinal obstruction); 3. Radiologica; evidence suggests that there is an empty or necrotic tumor; 4. Radiological evidence (CT or MRI) indicates the presence of a central type of tumor invading local large vessels; 5. Patients with abnormal blood coagulation(NR>1.5×ULNAPTT>1.5×ULN), bleeding tendency, receiving anticoagulant or antiplatelet drugs; severe thrombosis or clinically related severe bleeding events in the past 6 months; hereditary hemorrhage or thrombosis tendency; clinically significant hemoptysis has occurred in the past 3 months; 6. Central nervous system with symptoms of metastasis; 7. Pregnant or lactating women; 8. Other patients who were considered unsuitable for inclusion by physicians.

Design outcomes

Primary

MeasureTime frame
Progression free survival;

Secondary

MeasureTime frame
Overall survival;disease control rate;objective remission rate;safety;

Countries

China

Contacts

Public ContactQinxiang Guo, Weihua Yang

Shanxi Tumor Hospital

sxzlhx1@hotmail.com+86 13503503193

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026