Back to results

Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy (WUHIPEC01)

Primary Purpose

Gastric Cancer, Chemotherapy Effect, Surgery

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Paclitaxel

Lobaplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring advanced gastric cancer, hyperthermic intraperitoneal chemotherapy, lobaplatin, paclitaxel, prognosis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;
Aged 18-75 years;
Male or non-pregnant or lactating women;
Pathological diagnosis of gastric adenocarcinoma;
Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);
Normal function of major organs;
Routine blood examinations meeting the following criteria:
A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;
Chemistry indexs meeting the following criteria:
A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula);
ECOG score 0-1;

Exclusion Criteria:

A history of other malignant tumors within 5 years;
Distant metastasis found during surgery;
Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;
Suffering from epilepsy or other mental illness, unable to control behavior;
Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;
Pregnant or lactating women.
Receiving anti-cancer drug therapy from other clinical trials.

Sites / Locations

Wuhan Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

Drug group 1

Drug group 2

Control group

Arm Description

hyperthermic intraperitoneal chemotherapy (HIPEC) (with paclitaxel): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

hyperthermic intraperitoneal chemotherapy (HIPEC) (with lobaplatin): Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

hyperthermic intraperitoneal therapy (HIPET) (no drug) : Temperature Setting : 43 ± 1.0 ℃. Perfusion time: 60 min. Amount of perfusate: The perfusion fluid is based on the principle of filling the abdominal cavity and unobstructed circulation. Choice of perfusate: Normal saline. Drug selection and dose: no drug. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Outcomes

Primary Outcome Measures

peritoneal metastasis

peritoneal metastasis-free survival (pRFS)

overall survival

overall survival (OS)

Secondary Outcome Measures

Number of participants with immunosuppression events as assessed by blood immunological indicators

Before and After Hyperthermic Intraperitoneal Chemotherapy, collect 5mL blood samples of patients for detecting immunological indicators such as CD3, CD4 and CD8 lymphocyte population; Interferon-γ; tumor necrosis factor (TNF)-α; interleukin-2, 4, 8, 10, etc

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

postoperative adverse events (referring to CTCAE 5.0 [including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events]) was analyzed

The positive rate of cancer cells of participants by exfoliative cytology examination

According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed.

Full Information

NCT ID

NCT04808466

First Posted

February 17, 2021

Last Updated

February 18, 2022

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT04808466

Brief Title

Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Acronym

WUHIPEC01

Official Title

Comparative Study on the Efficacy of Lobaplatin and Paclitaxel in the Treatment of Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 18, 2021 (Actual)

Primary Completion Date

September 1, 2022 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a prospective, randomized, comparative clinical trial conducted by Wuhan Union Hospital and aim to compare the therapeutic effects of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with hyperthermic intraperitoneal chemotherapy

Detailed Description

Hyperthermic intraperitoneal chemotherapy (HIPEC) is traditionally used to treat peritoneal cancer combined with cytoreductive surgery (CRS). Further, there have been lots of randomized clinical trials assessing the efficacy of surgery + HIPEC for the treatment of locally advanced gastric cancer conducted. Nonetheless, to date, the kinds, doses, combinations of HIPEC drugs are not clearly been evaluate a criterion. Thus, This study aim to compare the efficacy of Lobaplatin and Paclitaxel in advanced gastric cancer patients with D2 surgery combined with HIPEC. We plan to recruit 231 patients and divide into 3 groups, 2 drug groups and 1 control groups, radomly. all patients with advanced gastric cancer receive D2 surgery + HIPEC + SOX/XELOX chemotherapy regimen. the mainly experimental variable is HIPEC drugs and three groups employ Lobaplatin, Paclitaxel and none respectively. the endpoints of study include peritoneal metastasis, overall survival, immune status and perioperative safety assessment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer, Chemotherapy Effect, Surgery, Metastasis, Survival

Keywords

advanced gastric cancer, hyperthermic intraperitoneal chemotherapy, lobaplatin, paclitaxel, prognosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

We divide patients into 3 groups randomly. Test group 1: D2 Surgery + HIPEC (paclitaxel) + SOX/XELOX regimen Test group 2: D2 Surgery + HIPEC (lobaplatin) + SOX/XELOX regimen Control group: D2 Surgery + HIPEC (no drug) + SOX/XELOX regimen

Masking

Participant

Masking Description

the choice of HIPEC drugs is unknown to patients with advanced gastric cancer, but known to doctors, investigators and outcomes assessors.

Allocation

Randomized

Enrollment

231 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Drug group 1

Arm Type

Experimental

Arm Description

Arm Title

Drug group 2

Arm Type

Experimental

Arm Description

Arm Title

Control group

Arm Type

No Intervention

Arm Description

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Paclitaxel is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Intervention Type

Drug

Intervention Name(s)

Lobaplatin

Intervention Description

Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).

Primary Outcome Measure Information:

Title

peritoneal metastasis

Description

peritoneal metastasis-free survival (pRFS)

Time Frame

3-year

Title

overall survival

Description

overall survival (OS)

Time Frame

3-year

Secondary Outcome Measure Information:

Title

Number of participants with immunosuppression events as assessed by blood immunological indicators

Description

Time Frame

up to 4 weeks

Title

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

Description

postoperative adverse events (referring to CTCAE 5.0 [including blood routine, liver and kidney function, patient reaction to HIPEC, adverse events]) was analyzed

Time Frame

up to 4 weeks

Title

The positive rate of cancer cells of participants by exfoliative cytology examination

Description

According to the positive rate of cancer cells measured in exfoliative cytology before and after HIPEC, the difference between the groups is analyzed.

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: No chemoradiotherapy or other anti-tumor therapy before clinical trial performed; Aged 18-75 years; Male or non-pregnant or lactating women; Pathological diagnosis of gastric adenocarcinoma; Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018); Normal function of major organs; Routine blood examinations meeting the following criteria: A. HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L; Chemistry indexs meeting the following criteria: A. TBIL < 1.5ULN; B. ALT and AST < 2.5ULN; ALB > 30 g/L C. serum Cr ≤ 1.25 ULN or endogenous creatinine clearance > 50 ml/min (Cockcroft-Gault formula); ECOG score 0-1; Exclusion Criteria: A history of other malignant tumors within 5 years; Distant metastasis found during surgery; Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs; Suffering from epilepsy or other mental illness, unable to control behavior; Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease; Pregnant or lactating women. Receiving anti-cancer drug therapy from other clinical trials.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaixiong Tao, Professor

Phone

+86- 027-85351662

kaixiongtao@hust.edu.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Yao Lin, Doctor

Phone

+86-13294158510

linyaomt@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaixiong Tao, Professor

Organizational Affiliation

Wuhan Union Hospital, China

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wuhan Union Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaixiong Tao

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

we would like to share IPD to other researchers 1 years after clinical trial finished

IPD Sharing Time Frame

we would like to share IPD to other researchers 1 years after clinical trial finished

IPD Sharing Access Criteria

all data should not been used for commercial purpose and other private purpose and only for academic research

Citations:

PubMed Identifier

11547741

Citation

Macdonald JS, Smalley SR, Benedetti J, Hundahl SA, Estes NC, Stemmermann GN, Haller DG, Ajani JA, Gunderson LL, Jessup JM, Martenson JA. Chemoradiotherapy after surgery compared with surgery alone for adenocarcinoma of the stomach or gastroesophageal junction. N Engl J Med. 2001 Sep 6;345(10):725-30. doi: 10.1056/NEJMoa010187.

Results Reference

background

PubMed Identifier

11813623

Citation

Yonemura Y, de Aretxabala X, Fujimura T, Fushida S, Katayama K, Bandou E, Sugiyama K, Kawamura T, Kinoshita K, Endou Y, Sasaki T. Intraoperative chemohyperthermic peritoneal perfusion as an adjuvant to gastric cancer: final results of a randomized controlled study. Hepatogastroenterology. 2001 Nov-Dec;48(42):1776-82.

Results Reference

result

PubMed Identifier

10091726

Citation

Fujimoto S, Takahashi M, Mutou T, Kobayashi K, Toyosawa T. Successful intraperitoneal hyperthermic chemoperfusion for the prevention of postoperative peritoneal recurrence in patients with advanced gastric carcinoma. Cancer. 1999 Feb 1;85(3):529-34.

Results Reference

result

PubMed Identifier

32306237

Citation

Torphy RJ, Stewart C, Sharma P, Halpern AL, Oase K, Herter W, Bartsch C, Friedman C, Del Chiaro M, Schulick RD, Gleisner A, McCarter MD, Ahrendt SA. Dextrose-Containing Carrier Solution for Hyperthermic Intraperitoneal Chemotherapy: Increased Intraoperative Hyperglycemia and Postoperative Complications. Ann Surg Oncol. 2020 Dec;27(13):4874-4882. doi: 10.1245/s10434-020-08330-y. Epub 2020 Apr 19.

Results Reference

result

PubMed Identifier

8156509

Citation

Hamazoe R, Maeta M, Kaibara N. Intraperitoneal thermochemotherapy for prevention of peritoneal recurrence of gastric cancer. Final results of a randomized controlled study. Cancer. 1994 Apr 15;73(8):2048-52. doi: 10.1002/1097-0142(19940415)73:83.0.co;2-q.

Results Reference

result

Learn more about this trial

Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy

We'll reach out to this number within 24 hrs