HIPEC Combined With Sintilimab for Gastric Cancer With Peritoneal Metastasis

NCT05648487 | Not Yet Recruiting Phase 2

• 1 other identifier: HIPEC-10
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the Safety and Efficacy of HIPEC Combined With Sintilimab for Gastric Cancer Patients with Peritoneal Metastasis.

Conditions

Gastric Cancer

Keywords

Gastric Cancer; Peritoneal Metastasis; HIPEC; PD1

Outcome Measures

Primary Outcomes (1)

• R0 resection

  the rate of R0 resection

  3 months

Secondary Outcomes (4)

• Overall survival time

  2 years

• ORR

  3 months

• Event-Free Survival

  2 years

• Relapse-Free Survival

  2 years

Study Arms (1)

Gastric Cancer With Peritoneal Metastasis, HIPEC, Anti-PD-1 Antibody

EXPERIMENTAL

1. Surgical exploration, if PCI≤20, then we perform this study. 2. HIPEC: HIPEC is performed after laparoscopic exploration, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgical exploration; 3. Chemotherapy(SOX) and anti-PD-1 antibody Sintilimab (Tyvyt®) treatment followed (4 cycles): SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 4 cycles; Sintilimab (Tyvyt®) 200mg fixed dose every 3 weeks, for a total of 4 cycles. 4. Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). After the surgery, HIPEC for three cycles, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgery; For inoperable patients, continue to use standard chemotherapy. 5. After the surgery, continue to use standard adjuvant chemotherapy.

Drug: HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery

Interventions

HIPEC,anti-PD-1 antibody Sintilimab (Tyvyt®), Chemotherapy,Surgery DRUG

1. HIPEC: HIPEC is performed after laparoscopic exploration, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgical exploration. 2. Chemotherapy(SOX) and anti-PD-1 antibody Sintilimab (Tyvyt®) treatment followed (4 cycles): SOX regimen: Oxaliplatin: 130 mg/m\^2, IV, d1; S-1, 40-60 mg/m\^2 bid, po, day 1-14, every 3 weeks for a total of 4 cycles; Sintilimab (Tyvyt®) 200mg fixed dose every 3 weeks, for a total of 4 cycles. 3. Surgery: Imaging and secondary surgical exploration, assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases). For patients undergoing surgery, HIPEC for three cycles followed, Mitomycin 30mg/m2, d1, Docetaxel 40mg/m2, d3, Oxaliplatin 65mg/m2, d5 within a week after surgery; For inoperable patients, continue to use standard chemotherapy of guidelines recommend. 4. After the surgery, continue to use standard adjuvant chemotherapy.

Gastric Cancer With Peritoneal Metastasis, HIPEC, Anti-PD-1 Antibody

Eligibility Criteria

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

You may qualify if:

• Advanced gastric (gastroesophageal junction) adenocarcinoma confirmed by histology;
• Age 18-75 years, Male or Non pregnant female
• ECOG (Eastern Cooperative Oncology Group) : 0\~1；
• Negative for HER-2 by IHC/FISH；
• Peritoneal metastasis is confirmed by laparoscopic exploration, and the PCI≤20；
• Untreated (e.g. radiotherapy, chemotherapy, target therapy and immunotherapy);
• Normal Bone marrow, liver and kidney function indices before the recruitment:
• Expected survival≥ 12 week
• Signed the Informed Consent Form, and blood and tissue samples can be obtained;

You may not qualify if:

• Other distal metastases besides peritoneal metastases (e.g., liver, lung, pleural, brain, bone metastases, etc.);
• Previous systemic therapy for gastric cancer;
• Recurrent gastric cancer after surgery;
• Cardiopulmonary dysfunction;
• Immunosuppressive drugs(eg.Corticosteroids) were used within 14 days before treatment, eg.corticosteroids,
• There is any active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or asthma in childhood have been completely relieved, and those who do not need any intervention after adulthood can be included Asthma requiring medical intervention with bronchodilator was not included.)
• Allergy to the drugs in this protocol；
• A history of idiopathic pulmonary fibrosis, tissue pneumonia, drug pneumonia, idiopathic pneumonia, or r active pneumonia;

Sponsors & Collaborators

• Affiliated Cancer Hospital & Institute of Guangzhou Medical University: lead

Related Publications (6)

• Al-Batran SE, Homann N, Pauligk C, Illerhaus G, Martens UM, Stoehlmacher J, Schmalenberg H, Luley KB, Prasnikar N, Egger M, Probst S, Messmann H, Moehler M, Fischbach W, Hartmann JT, Mayer F, Hoffkes HG, Koenigsmann M, Arnold D, Kraus TW, Grimm K, Berkhoff S, Post S, Jager E, Bechstein W, Ronellenfitsch U, Monig S, Hofheinz RD. Effect of Neoadjuvant Chemotherapy Followed by Surgical Resection on Survival in Patients With Limited Metastatic Gastric or Gastroesophageal Junction Cancer: The AIO-FLOT3 Trial. JAMA Oncol. 2017 Sep 1;3(9):1237-1244. doi: 10.1001/jamaoncol.2017.0515.

  PMID: 28448662 BACKGROUND

• Okabe H, Ueda S, Obama K, Hosogi H, Sakai Y. Induction chemotherapy with S-1 plus cisplatin followed by surgery for treatment of gastric cancer with peritoneal dissemination. Ann Surg Oncol. 2009 Dec;16(12):3227-36. doi: 10.1245/s10434-009-0706-z. Epub 2009 Sep 24.

  PMID: 19777180 BACKGROUND

• Ishigami H, Fujiwara Y, Fukushima R, Nashimoto A, Yabusaki H, Imano M, Imamoto H, Kodera Y, Uenosono Y, Amagai K, Kadowaki S, Miwa H, Yamaguchi H, Yamaguchi T, Miyaji T, Kitayama J. Phase III Trial Comparing Intraperitoneal and Intravenous Paclitaxel Plus S-1 Versus Cisplatin Plus S-1 in Patients With Gastric Cancer With Peritoneal Metastasis: PHOENIX-GC Trial. J Clin Oncol. 2018 Jul 1;36(19):1922-1929. doi: 10.1200/JCO.2018.77.8613. Epub 2018 May 10.

  PMID: 29746229 BACKGROUND

• Yang XJ, Huang CQ, Suo T, Mei LJ, Yang GL, Cheng FL, Zhou YF, Xiong B, Yonemura Y, Li Y. Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy improves survival of patients with peritoneal carcinomatosis from gastric cancer: final results of a phase III randomized clinical trial. Ann Surg Oncol. 2011 Jun;18(6):1575-81. doi: 10.1245/s10434-011-1631-5. Epub 2011 Mar 23.

  PMID: 21431408 BACKGROUND

• Jiang H, Yu X, Li N, Kong M, Ma Z, Zhou D, Wang W, Wang H, Wang H, He K, Li Z, Lu Y, Zhang J, Zhao K, Zhang Y, Xu N, Li Z, Liu Y, Wang Y, Wang Y, Teng L. Efficacy and safety of neoadjuvant sintilimab, oxaliplatin and capecitabine in patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma: early results of a phase 2 study. J Immunother Cancer. 2022 Mar;10(3):e003635. doi: 10.1136/jitc-2021-003635.

  PMID: 35296556 BACKGROUND

• Bonnot PE, Piessen G, Kepenekian V, Decullier E, Pocard M, Meunier B, Bereder JM, Abboud K, Marchal F, Quenet F, Goere D, Msika S, Arvieux C, Pirro N, Wernert R, Rat P, Gagniere J, Lefevre JH, Courvoisier T, Kianmanesh R, Vaudoyer D, Rivoire M, Meeus P, Passot G, Glehen O; FREGAT and BIG-RENAPE Networks. Cytoreductive Surgery With or Without Hyperthermic Intraperitoneal Chemotherapy for Gastric Cancer With Peritoneal Metastases (CYTO-CHIP study): A Propensity Score Analysis. J Clin Oncol. 2019 Aug 10;37(23):2028-2040. doi: 10.1200/JCO.18.01688. Epub 2019 May 14.

  PMID: 31084544 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Drug Therapy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Shuzhong Cui, Doctor

  Affiliated Cancer Hospital & Institute of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ziying Lei, Doctor

CONTACT

(086)020-66673666; leiziyinggz@126.com

Shuzhong Cui, Doctor

CONTACT

086-138-0251-3800; cuishuzhong@gzhmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2022
• First Posted: December 13, 2022
• Study Start: January 1, 2023
• Primary Completion: March 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 16, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share