## Protocol Section
### Identification Module
**NCT ID:** NCT06413212

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

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

#### Organization Study ID Info
**ID:** TJ-IRB20230704
#### Organization
**Class:** OTHER
**Full Name:** Tongji Hospital
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-08

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-08-04

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-01-14
**Study First Submit QC Date:** 2024-05-08
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** Beijing GeneX MedLab Co., Ltd

#### Lead Sponsor

**Class:** OTHER

**Name:** Liu Huang

#### Responsible Party

**Investigator Affiliation:** Tongji Hospital

**Investigator Full Name:** Liu Huang

**Investigator Title:** Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

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

**Detailed 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.

### Conditions Module

**Conditions:**

- Lung Cancer

- Breast Cancer

- Gastric Cancer

- Colorectal Cancer

**Keywords:**

- PTC: Patient-derived tumor-like cell clusters

### Design Module

#### Bio Spec

**Description:** Malignant effusion

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 55

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Participants who were diagnosed as advanced malignancy and would receive 2 cycles of personal therapy based on PTC drug screening tests.

**Intervention Names:**

- Diagnostic Test: Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.

**Label:** Case group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Case group

**Description:** 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.

**Name:** Patient-derived tumor-like cell clusters (PTC) drug sensitivity testing.

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Complete Response (CR)

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Partial Response (PR)

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Progressive Disease (PD)

**Time Frame:** up to 12 months

**Description:** 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.

**Measure:** Stable Disease (SD)

**Time Frame:** up to 12 months

### Eligibility Module

**Eligibility Criteria:** 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.

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Cancer patients with malignant effusion, above 18 years of age, at Tongji Hospital, Tongji Medical College of HUST

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** huangliu@tjh.tjmu.edu.cn

**Name:** Liu Huang

**Phone:** 63639656

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Wuhan

**Contacts:**

***Contact 1:***

- **Email:** huangliu@tjh.tjmu.edu.cn

- **Name:** Liu Huang

- **Phone:** 63639656

- **Role:** CONTACT

**Country:** China

**Facility:** Tongji Hospital

**State:** Hubei

**Status:** RECRUITING

**Zip:** 430030

#### Overall Officials

**Official 1:**

**Affiliation:** Tongji Hospital

**Name:** Liu Huang

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010335

- Term: Pathologic Processes

- ID: D000010995

- Term: Pleural Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC20

- Name: Immune System Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M16064

- Name: Stomach Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M11172

- Name: Lung Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M4509

- Name: Ascites

- Relevance: HIGH

- As Found: Ascites

- ID: M9931

- Name: Hydrothorax

- Relevance: HIGH

- As Found: Hydrothorax

- ID: M13885

- Name: Pleural Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T5486

- Name: Stomach Cancer

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006876

- Term: Hydrothorax

- ID: D000001201

- Term: Ascites

### Misc Info Module

- Version Holder: 2024-05-31
