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

Surgery Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808466
• Other study ID #: UHCT-IEC-SOP-016-21-01
• Status: Recruiting
• Phase: Phase 2
• Start date: September 18, 2021
• Est. completion date: September 1, 2025

Study information

• Verified date: September 2021
• Source: Wuhan Union Hospital, China
• Contact: Kaixiong Tao, Professor
• Phone: +86- 027-85351662
• Email: kaixiongtao[@]hust.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 231
• Est. completion date: September 1, 2025
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. No chemoradiotherapy or other anti-tumor therapy before clinical trial performed;

2. Aged 18-75 years;

3. Male or non-pregnant or lactating women;

4. Pathological diagnosis of gastric adenocarcinoma;

5. Clinical diagnosis of T3 stage or above without distant metastasis and can be given D2 radical resection (AJCC Version 8, 2018);

6. Normal function of major organs;

7. 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;

8. 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);

9. ECOG score 0-1;

Exclusion Criteria:

1. A history of other malignant tumors within 5 years;

2. Distant metastasis found during surgery;

3. Allergic to paclitaxel, lobaplatin and other related chemotherapeutic drugs;

4. Suffering from epilepsy or other mental illness, unable to control behavior;

5. Inability to tolerate surgery due to severe cardiac, pulmonary and vascular disease;

6. Pregnant or lactating women.

7. Receiving anti-cancer drug therapy from other clinical trials.

Related Conditions & MeSH terms

• Chemotherapy Effect
• Fever
• Gastric Cancer
• Hyperthermia
• Metastasis
• Stomach Neoplasms
• Surgery
• Survival

Intervention

Drug:
• Paclitaxel
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).
• Lobaplatin
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).

Locations

Country	Name	City	State
China	Wuhan Union Hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Wuhan Union Hospital, China

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View 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. — View 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. — View 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 Intraoperati — View 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 control — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peritoneal metastasis	peritoneal metastasis-free survival (pRFS)	3-year
Primary	overall survival	overall survival (OS)	3-year
Secondary	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-?; tumor necrosis factor (TNF)-a; interleukin-2, 4, 8, 10, etc	up to 4 weeks
Secondary	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	up to 4 weeks
Secondary	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.	1 week