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Gastric CancerPhase 2WUHIPEC01NCT04808466

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

A Phase 2 study testing Paclitaxel and Lobaplatin in people with Gastric Cancer and Chemotherapy Effect, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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 Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Chemotherapy Effect, Surgery
What is being tested?
Paclitaxel and Lobaplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
1 siteChina
Study dates
18 Sep 2021to 1 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 11Show fewer
  • Routine blood examinations meeting the following criteria:
  • HB ≥ 90 g/L; B. ANC ≥ 1.5 x 10 9 /L; C. PLT ≥ 125 × 10 9 /L;
  • Chemistry indexs meeting the following criteria:
  • 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;

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Kaixiong Tao, Professor contact

+86- 027-85351662

kaixiongtao@hust.edu.cn

Yao Lin, Doctor contact

+86-13294158510

linyaomt@163.com

China1 site, 1 recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei, 430000

    Kaixiong Tao

    Recruiting

Other trials in China

About this study

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

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

Read the 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.

Being tested
Paclitaxel, Lobaplatin
Keywords
advanced gastric cancer, hyperthermic intraperitoneal chemotherapy, lobaplatin, paclitaxel, prognosis
Medical subject headings
Stomach Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    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).

  • LobaplatinDrug

    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).

Study groups in NCT04808466
Study groupRoleWhat they receive
Drug group 1Experimentalhyperthermic 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).
Receives: Drug: Paclitaxel
Drug group 2Experimentalhyperthermic 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).
Receives: Drug: Lobaplatin
Control groupNo interventionhyperthermic 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. peritoneal metastasis

    peritoneal metastasis-free survival (pRFS)

    Measured: 3-year

  2. overall survival

    overall survival (OS)

    Measured: 3-year

Secondary outcomes (3)

  1. 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

    Measured: up to 4 weeks

  2. 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

    Measured: up to 4 weeks

  3. 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.

    Measured: 1 week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2021
  2. Study start18 Sep 2021
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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
Single blind
Who is masked
Participant
Enrolment
231 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04808466
Sponsor's protocol ID
UHCT-IEC-SOP-016-21-01
Acronym
WUHIPEC01
Status last verified
Sep 2021
First submitted
17 Feb 2021
Last updated
21 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: we would like to share IPD to other researchers 1 years after clinical trial finished

Publications

  • 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.

    PubMed 11547741

  • 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.

    PubMed 11813623

  • 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.

    PubMed 10091726

  • 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.

    PubMed 32306237

  • 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.

    PubMed 8156509

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Paclitaxel and Lobaplatin in people with Gastric Cancer and Chemotherapy Effect, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Kaixiong Tao, Professor (+86- 027-85351662, kaixiongtao@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

peritoneal metastasis (time frame: 3-year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04808466, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2022.

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