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Clinical study of Apapinib Combination with Crizotinib in Patients with Non-small cell lung cancer(NSCLC) who Developed Crizotinib Acpuired Resistance

Clinical study of Apapinib Combination with Crizotinib in Patients with Non-small cell lung cancer(NSCLC) who Developed Crizotinib Acpuired Resistance

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17013276
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

Case series:Apapinib Combination with Crizotinib

Sponsors

Shanxi Tumor Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1. Aged 18-75, male and female; 2. Non-small cell lung cancer diagnosed by pathology, clinical staging IIIB or above; 3. Patients with lung cancer treated with Crizotinib failed; 4. At least one imaging examination of measurable lesions (RECIST), spiral CT or MR should be = 10 mm; 5. ECOG physical status score: 0-2 points; 6. Expected survival = 3 months; 7. Blood routine meets the following criteria: WBC =3.5×10^9/L; ANC =1.5×10^9/L; HB =80 g/L; PLT =70×10^9/L; Blood biochemistry meets the following criteria: No hepatic metastasis; ALT = 2.5×ULN; If there is hepatic metastasisALT = 5×ULN. 8. After the operation, the wound healed completely without bleeding tendency; 9. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and have a negative result and are willing to use appropriate methods for contraception at 8 weeks after the trial and at the end of the last test.For men, consent should be given to appropriate contraception or surgical sterilization 8 weeks after the trial and at the last time the test drug was given; 10. The patient volunteered to participate in this study and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Suffering from hypertension, antihypertensive drug therapy can not be reduced to the normal range (Systolic blood pressure> 140 mmHg / diastolic blood pressure> 90 mmHg), suffering from = II level of coronary heart disease, arrhythmia(Including QTc interval prolongation, male > 450 ms,female>470 ms) and heart failure; 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; 6. Pregnant or lactating women; 7. 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 ContactBinbin Shan, Weihua Yang

Shanxi Tumor Hospital

sxzlhx1@hotmail.com+86 13593134034

Outcome results

None listed

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