Skip to content

Single-center, open-label, prospective clinical study of pemetrexed monotherapy after pemetrexed in combination with lobaplatin in the treatment of advanced lung adenocarcinoma

Single-center, open-label, prospective clinical study of pemetrexed monotherapy after pemetrexed in combination with lobaplatin in the treatment of advanced lung adenocarcinoma

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800019818
Enrollment
Unknown
Registered
2018-11-30
Start date
2018-12-31
Completion date
Unknown
Last updated
2018-12-04

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

Conditions

Advanced lung adenocarcinoma

Interventions

Case series:Pemetrexe+Pemetrexe

Sponsors

The Fifth Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with newly diagnosed advanced lung adenocarcinoma, and patients are not suitable or refused to target therapy; 2. Histological evidence for the diagnosis of lung adenocarcinoma; 3. older than 18 years old; 4. The subject has at least one measurable tumor lesion (the tumor lesion is considered unmeasurable at the site where the radiation therapy was previously performed); 5. The PS score is 0-1 points (ECOG); 6. Adequate bone marrow function: peripheral blood leukocytes > 4.0X10^9/L, neutrophil cells > 2.0X10^9/L, hemoglobin > 90g/L, platelets > 100X10^9/L (No blood transfusion and blood products within 14 days, not corrected by G-CSF and other hematopoietic stimuli); 7. Normal liver and kidney function: AST, ALT < 2.5 times the upper limit of normal (the liver metastasis can be relaxed to 5 times the upper limit of normal), total bilirubin < 1.5 times the upper limit of normal; creatinine clearance = 60mL/min; 8. Life expectancy is greater than 12 weeks; 9. Sign the dated informed consent form before the specific proposed steps begin; 10. Follow the regular follow-up; 11. Patients with unobstructed coagulation mechanisms; 12. Ability to comply with the requirements of the test.

Exclusion criteria

Exclusion criteria: 1. The patient is suitable and willing to receive targeted therapy; 2. Serious clinical infection (> grade 2 NCI-CTC V4.0); 3. Active infections require antimicrobial treatment (eg antibiotics, antiviral drugs, chronic hepatitis B anti-hepatitis B treatment, antifungal therapy); 4. A person with a history of psychotropic substance abuse who is unable to quit or has a mental disorder; 5. The patient has a central nervous system metastasis and has clinical symptoms; 6. The patient's physical condition is life-threatening; 7. A pregnant or breast-feeding patient. A female patient who is pregnant may have to check for a negative pregnancy within 7 days of the start of treatment to continue. Patients enrolled in the trial (both men and women) must take contraceptive measures during the trial period until two weeks after the trial is completed; 8. PS score = 2; 9. Have a history of peripheral neurological disease (NCI CTC AE4.0 level = 2); 10. Patients with a coagulopathy disorder (INR > 1.5 or prothrombin time PT > ULN + 4 or APTT > 1.5 ULN), have a bleeding tendency or are receiving thrombolytic or anticoagulant therapy; 11. The daily hemoptysis was 2 teaspoons or more before enrollment; 12. Long-term unhealed wounds or fractures (not associated with pathological fractures caused by tumors); 13. There are clinical symptoms, serous effusions (including pleural effusion, ascites, pericardial effusion) that require symptomatic treatment. Note: Asymptomatic serous effusion can be enrolled, symptomatic serous effusion after active symptomatic treatment (can not use anticancer drugs for the treatment of serosal effusion), patients who can be enrolled by the investigator, allowed to join; 14. There are other serious diseases at the same time. A patient who has had or is suffering from a tumor whose primary site or histology is different from the tumor evaluated in this study. Except for cervical carcinoma in situ, cured basal cell carcinoma, bladder surface tumor [Ta, Tis & T1], or any cured tumor that was enrolled in the study for more than 3 years; 15. The patient refused to participate; 16. The investigator judges other conditions that may affect clinical research and the outcome of the study.

Design outcomes

Primary

MeasureTime frame
Complete blood count;Tumor assessment;Quality of life score;

Countries

China

Contacts

Public ContactLin Zhong

The Fifth Affiliated Hospital of Zhongshan University

linzhong123@163.com+86 13570604449

Outcome results

None listed

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