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

NCT04808466 | Unknown Phase 2 DMC

• 1 other identifier: UHCT-IEC-SOP-016-21-01
• Study Type: interventional
• Target: 231
• Locations: 1 country
• Sites: 1

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

Conditions

Gastric Cancer; Chemotherapy Effect; Surgery; Metastasis; Survival

Keywords

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

Outcome Measures

Primary Outcomes (2)

• peritoneal metastasis

  peritoneal metastasis-free survival (pRFS)

  3-year

• overall survival

  overall survival (OS)

  3-year

Secondary Outcomes (3)

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

  up to 4 weeks

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

  up to 4 weeks

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

  1 week

Study Arms (3)

Drug group 1

EXPERIMENTAL

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).

Drug: Paclitaxel

Drug group 2

EXPERIMENTAL

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).

Drug: Lobaplatin

Control group

NO INTERVENTION

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).

Interventions

Paclitaxel DRUG

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).

Drug group 1

Lobaplatin DRUG

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).

Drug group 2

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Wuhan Union Hospital

Wuhan, Hubei, 430000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 11547741 BACKGROUND

• 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.

  PMID: 11813623 RESULT

• 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.

  PMID: 10091726 RESULT

• 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.

  PMID: 32306237 RESULT

• 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.

  PMID: 8156509 RESULT

MeSH Terms

Conditions

Stomach Neoplasms; Neoplasm Metastasis

Interventions

Paclitaxel; lobaplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kaixiong Tao, Professor

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaixiong Tao, Professor

CONTACT

+86- 027-85351662; kaixiongtao@hust.edu.cn

Yao Lin, Doctor

CONTACT

+86-13294158510; linyaomt@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: the choice of HIPEC drugs is unknown to patients with advanced gastric cancer, but known to doctors, investigators and outcomes assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: March 22, 2021
• Study Start: September 18, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2025
• Last Updated: February 21, 2022

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: we would like to share IPD to other researchers 1 years after clinical trial finished
• Access Criteria: all data should not been used for commercial purpose and other private purpose and only for academic research

Locations

CN (1)