Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing

Breast Cancer Clinical Trial

Official title:

Exploratory Study of Precise Therapy for Advanced Tumor Patients With Malignant Hydrothorax or Ascites by Using PTC Drug Sensitivity Testing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06413212
• Other study ID #: TJ-IRB20230704
• Status: Recruiting
• Start date: August 4, 2023
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Tongji Hospital
• Contact: Liu Huang
• Phone: 63639656
• Email: huangliu[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To explore the consistency between result of PTC drug screening tests and actual clinical outcome for patients with advanced malignancy.

Description:

This study is anticipated to enroll 55 patients with advanced malignancy, and fresh malignant effusion samples collected from patients would be detected by PTC drug screening. In addition, patients would receive 2 cycles of personal therapy based on results of screening tests. By combining PTC drug sensitivity results with patient's treatment process and clinical feedback, researchers may evaluate the sensitiveness and specificity of PTC drug screening technique in predicting clinical outcome for advanced malignancy patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 to 75 years old, regardless of gender.

2. Score of nutrition risk screening 2002 (NRS2002) is less than 3, NRS20023.

3. Advanced and unresectable malignancy confirmed by biopsy diagnosis.

4. Able to tolerate anti-tumor treatment, and without serious cardiopulmonary and other underlying diseases.

5. Score of eastern cooperative oncology group (ECOG) is not higher than 2, ECOG=2.

6. Anticipated survival exceed six months.

7. At least one measurable lesions (according to RECIST 1.1)

8. Resistance or intolerance to standard therapy regimens.

9. Signed informed consent form voluntarily.

Exclusion Criteria:

1. Pregnant or lactating women.

2. Have Participated other clinical trials in six months.

3. Severe liver dysfunction.

4. Severe renal dysfunction.

5. Patients with cognitive disorder, mental diseases and terrible compliance.

6. Allergic to known chemotherapeutic agents.

7. Other circumstance not suitable to participate in this trial determined by investigators.

Related Conditions & MeSH terms

• Ascites
• Breast Cancer
• Colorectal Cancer
• Gastric Cancer
• Hydrothorax
• Lung Cancer

Intervention

Diagnostic Test:
• Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.
Fresh malignant effusion samples were collected from advanced malignancy patients for PTC drug sensitivity testing, then assess the accuracy of this diagnostic test by combination and analysis with final clinical outcome.

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Liu Huang	Beijing GeneX MedLab Co., Ltd

Country where clinical trial is conducted

China, 

References & Publications (14)

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Reck M, Remon J, Hellmann MD. First-Line Immunotherapy for Non-Small-Cell Lung Cancer. J Clin Oncol. 2022 Feb 20;40(6):586-597. doi: 10.1200/JCO.21.01497. Epub 2022 Jan 5. Erratum In: J Clin Oncol. 2022 Apr 10;40(11):1265. — View Citation

Vlachogiannis G, Hedayat S, Vatsiou A, Jamin Y, Fernandez-Mateos J, Khan K, Lampis A, Eason K, Huntingford I, Burke R, Rata M, Koh DM, Tunariu N, Collins D, Hulkki-Wilson S, Ragulan C, Spiteri I, Moorcraft SY, Chau I, Rao S, Watkins D, Fotiadis N, Bali M, Darvish-Damavandi M, Lote H, Eltahir Z, Smyth EC, Begum R, Clarke PA, Hahne JC, Dowsett M, de Bono J, Workman P, Sadanandam A, Fassan M, Sansom OJ, Eccles S, Starling N, Braconi C, Sottoriva A, Robinson SP, Cunningham D, Valeri N. Patient-derived organoids model treatment response of metastatic gastrointestinal cancers. Science. 2018 Feb 23;359(6378):920-926. doi: 10.1126/science.aao2774. — View Citation

Wang X, Wang SS, Huang H, Cai L, Zhao L, Peng RJ, Lin Y, Tang J, Zeng J, Zhang LH, Ke YL, Wang XM, Liu XM, Chen QJ, Zhang AQ, Xu F, Bi XW, Huang JJ, Li JB, Pang DM, Xue C, Shi YX, He ZY, Lin HX, An X, Xia W, Cao Y, Guo Y, Su YH, Hua X, Wang XY, Hong RX, Jiang KK, Song CG, Huang ZZ, Shi W, Zhong YY, Yuan ZY; South China Breast Cancer Group (SCBCG). Effect of Capecitabine Maintenance Therapy Using Lower Dosage and Higher Frequency vs Observation on Disease-Free Survival Among Patients With Early-Stage Triple-Negative Breast Cancer Who Had Received Standard Treatment: The SYSUCC-001 Randomized Clinical Trial. JAMA. 2021 Jan 5;325(1):50-58. doi: 10.1001/jama.2020.23370. Erratum In: JAMA. 2022 May 17;327(19):1929. — View Citation

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* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete Response (CR)	Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Length is measured in millimeters, refers to RECIST 1.1.	up to 12 months
Primary	Partial Response (PR)	At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Length is measured in millimeters, refers to RECIST.1.1.	up to 12 months
Primary	Progressive Disease (PD)	At least a 20% increase in the sum of diameters of taraet lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm (the appearance of one or more new lesions is also considered progression). Length is measured in millimeters, refers to RECIST 1.1.	up to 12 months
Primary	Stable Disease (SD)	Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study. Length is measured in millimeters, refers to RECIST 1.1.	up to 12 months