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Gastric AdenocarcinomaNCT06798376

Different Cycles of Neoadjuvant PD-1 Blockades + Chemotherapy for Advanced Gastric Cancer

An observational study of Gastric Adenocarcinoma, run by Chinese PLA General Hospital at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this observational study is to analyze the impact of different durations of neoadjuvant PD-1 inhibitor combined with chemotherapy on tumor regression and safety in patients with advanced gastric cancer. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Gastric Adenocarcinoma
What is being tested?
2-4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy, 5-8 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy and Gastrectomy
Type of treatment
Surgery or procedure
How many people
409 participants
Where
1 siteChina
Study dates
16 Jan 2025to 31 Jan 2026
Phase
Observational
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 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Advanced gastric cancer patients who received preoperative PD-1 inhibitor combined with chemotherapy and gastrectomy

Who may be able to join

  • Non-bedridden patients aged 18-90 years;
  • Histologically confirmed gastric or gastroesophageal junction adenocarcinoma by biopsy;
  • Evaluated as resectable advanced gastric cancer via CT, MRI, or laparoscopic exploration;
  • No prior anti-tumor treatments such as chemotherapy, radiotherapy, or immunotherapy;
  • No history of other malignancies within the past 5 years;
  • Received at least one cycle of PD-1 inhibitor combined with chemotherapy preoperatively, with no restrictions on the specific PD-1 inhibitor or chemotherapeutic agents;
  • Underwent radical gastrectomy after neoadjuvant therapy;
  • No severe underlying diseases.

Who cannot join

  • Incomplete or inaccessible clinical and pathological data;
  • Postoperative pathology confirming non-gastric or non-gastroesophageal junction adenocarcinoma;
  • Distant metastases present prior to treatment;
  • Concurrent diagnosis of other malignancies.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Chinese PLA General Hospital

    Beijing, 100853

Other trials in China

About this study

Official title: The Comparison of Different Cycles of PD-1 Blockades Combined With Chemotherapy as Neoadjuvant Therapy for Patients With Advanced Gastric Cancer

The goal of this observational study is to analyze the impact of different durations of neoadjuvant PD-1 inhibitor combined with chemotherapy on tumor regression and safety in patients with advanced gastric cancer. The main questions it aims to answer are:

  • Does the duration of neoadjuvant treatment influence tumor regression grading (TRG)?
  • How does treatment duration affect perioperative safety and clinical outcomes?

Participants who have previously undergone neoadjuvant PD-1 inhibitor combined with chemotherapy followed by surgery as part of their routine medical care will have their clinical data retrospectively reviewed and analyzed.

Being tested
2-4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy, 5-8 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy, Gastrectomy
Keywords
Advanced Gastric Adenocarcinoma, Neoadjuvant, Immunotherapy, Chemotherapy, Cycles

What participants receive

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

  • 2-4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapyDrug

    Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for 2-4 cycles

  • 5-8 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapyDrug

    Any PD-1 inhibitors combined with any chemotherapy regimen given before surgery for 5-8 cycles

  • GastrectomyProcedure or surgery

    Any type of surgical procedure for gastric adenocarcinoma patients in which part or all of the stomach is removed

Study groups in NCT06798376
Study groupRoleWhat they receive
Group AThe group A contains participants who received 2-4 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Receives: Drug: 2-4 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy; Procedure: Gastrectomy
Group BThe group B contains participants who received 5-8 cycles of neoadjuvant PD-1 inhibitor combined with chemotherapy and then received gastrectomy.
Receives: Drug: 5-8 cycles of neoadjuvant PD-1 Inhibitors combined with chemotherapy; Procedure: Gastrectomy

What is being measured

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

  1. Tumor Regression Grading (TRG)

    Tumor Regression Grading (TRG) based on the NCCN guidelines ranging from 0 (no residual tumor) to 3 (extensive residual tumor cells with no or minimal tumor cell necrosis), with higher scores indicating worse outcomes.

    Measured: Approximately 1 week after surgery (when the pathology examination report available)

Secondary outcomes (8)

  1. Adverse events

    Adverse events during neoadjuvant therapy and postoperative complications

    Measured: From the start of neoadjuvant chemotherapy to 7 days after surgery

  2. R0 resection

    Complete removal of a tumor with no residual cancer cells at the surgical margins, confirmed by pathological examination

    Measured: Approximately 1 week after surgery (when the pathology examination report available)

  3. Operative time

    The total duration of a surgical procedure, measured from the first incision to the completion of wound closure

    Measured: On the day of the surgery (can be obtained immediately after the completion of the surgery)

  4. Time to first flatus

    The duration from the completion of surgery to the first passing of gas (flatus) by the patient

    Measured: From date of surgery until the date of first flatus, assessed up to 10 days post-surgery

  5. Nutritional Risk Screening 2002 (NRS 2002)

    The Nutritional Risk Screening 2002 (NRS 2002) is a scale used to assess the nutritional risk of hospitalized patients. The score ranges from 0 to 7, with higher scores indicating a higher risk of malnutrition. A score of 0 signifies no nutritional risk, while a score of 3 or higher indicates a significant nutritional risk that may require intervention.

    Measured: Approximately 1 week after completing all neoadjuvant therapy

  6. YpTNM staging

    Pathological classification used to assess cancer characteristics after neoadjuvant therapy, based on the American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th Edition.

    Measured: Approximately 1 week after surgery (when the pathology examination report available)

  7. Dissected lymph node number

    The total number of lymph nodes surgically removed and examined

    Measured: Approximately 1 week after surgery (when the pathology examination report available)

  8. Positive lymph node number

    The number of lymph nodes found to contain cancer cells upon pathological examination

    Measured: Approximately 1 week after surgery (when the pathology examination report available)

Timeline

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

  1. First posted29 Jan 2025
  2. Study start16 Jan 2025
  3. Primary completion30 Sep 2025
  4. Study completion31 Jan 2026

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
409 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06798376
Sponsor's protocol ID
S2024-823
Status last verified
Oct 2026
First submitted
16 Jan 2025
Last updated
21 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The datasets used and/or analyzed during the current study containing data related to the outcomes observed in the study, without any personal information or other data of the patients will be shared.

Publications

  • Hayashi T, Yoshikawa T, Sakamaki K, Nishikawa K, Fujitani K, Tanabe K, Misawa K, Matsui T, Miki A, Nemoto H, Fukunaga T, Kimura Y, Hihara J. Primary results of a randomized two-by-two factorial phase II trial comparing neoadjuvant chemotherapy with two and four courses of cisplatin/S-1 and docetaxel/cisplatin/S-1 as neoadjuvant chemotherapy for advanced gastric cancer. Ann Gastroenterol Surg. 2020 Jul 16;4(5):540-548. doi: 10.1002/ags3.12352. eCollection 2020 Sep.

    PubMed 33005849

  • Yoshikawa T, Tanabe K, Nishikawa K, Ito Y, Matsui T, Kimura Y, Hirabayashi N, Mikata S, Iwahashi M, Fukushima R, Takiguchi N, Miyashiro I, Morita S, Miyashita Y, Tsuburaya A, Sakamoto J. Induction of a pathological complete response by four courses of neoadjuvant chemotherapy for gastric cancer: early results of the randomized phase II COMPASS trial. Ann Surg Oncol. 2014 Jan;21(1):213-9. doi: 10.1245/s10434-013-3055-x. Epub 2013 Jul 10.

    PubMed 23838904

  • Lorenzen S, Gotze TO, Thuss-Patience P, Biebl M, Homann N, Schenk M, Lindig U, Heuer V, Kretzschmar A, Goekkurt E, Haag GM, Riera-Knorrenschild J, Bolling C, Hofheinz RD, Zhan T, Angermeier S, Ettrich TJ, Siebenhuener AR, Elshafei M, Bechstein WO, Gaiser T, Loose M, Sookthai D, Kopp C, Pauligk C, Al-Batran SE; AIO and SAKK Study Working Groups. Perioperative Atezolizumab Plus Fluorouracil, Leucovorin, Oxaliplatin, and Docetaxel for Resectable Esophagogastric Cancer: Interim Results From the Randomized, Multicenter, Phase II/III DANTE/IKF-s633 Trial. J Clin Oncol. 2024 Feb 1;42(4):410-420. doi: 10.1200/JCO.23.00975. Epub 2023 Nov 14.

    PubMed 37963317

  • Sun W, Veeramachaneni N, Al-Rajabi R, Madan R, Kasi A, Al-Kasspooles M, Baranda J, Saeed A, Phadnis MA, Godwin AK, Olyaee M, Streeter N, Nagji A, Dai J, Williamson S. A phase II study of perioperative pembrolizumab plus mFOLFOX in patients with potentially resectable esophagus, gastroesophageal junction (GEJ), and stomach adenocarcinoma. Cancer Med. 2023 Aug;12(15):16098-16107. doi: 10.1002/cam4.6263. Epub 2023 Jun 16.

    PubMed 37326317

  • Yuan SQ, Nie RC, Jin Y, Liang CC, Li YF, Jian R, Sun XW, Chen YB, Guan WL, Wang ZX, Qiu HB, Wang W, Chen S, Zhang DS, Ling YH, Xi SY, Cai MY, Huang CY, Yang QX, Liu ZM, Guan YX, Chen YM, Li JB, Tang XW, Peng JS, Zhou ZW, Xu RH, Wang F. Perioperative toripalimab and chemotherapy in locally advanced gastric or gastro-esophageal junction cancer: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):552-559. doi: 10.1038/s41591-023-02721-w. Epub 2024 Jan 2.

    PubMed 38167937

  • Raimondi A, Lonardi S, Murgioni S, Cardellino GG, Tamberi S, Strippoli A, Palermo F, De Manzoni G, Bencivenga M, Bittoni A, Chiodoni C, Lorenzini D, Todoerti K, Manca P, Sangaletti S, Prisciandaro M, Randon G, Nichetti F, Bergamo F, Brich S, Belfiore A, Bertolotti A, Stetco D, Guidi A, Torelli T, Vingiani A, Joshi RP, Khoshdeli M, Beaubier N, Stumpe MC, Nappo F, Leone AG, Pircher CC, Leoncini G, Sabella G, Airo' Farulla L, Alessi A, Morano F, Martinetti A, Niger M, Fassan M, Di Maio M, Kaneva K, Milione M, Nimeiri H, Sposito C, Agnelli L, Mazzaferro V, Di Bartolomeo M, Pietrantonio F. Tremelimumab and durvalumab as neoadjuvant or non-operative management strategy of patients with microsatellite instability-high resectable gastric or gastroesophageal junction adenocarcinoma: the INFINITY study by GONO. Ann Oncol. 2025 Mar;36(3):285-296. doi: 10.1016/j.annonc.2024.11.016. Epub 2024 Dec 3.

    PubMed 39637944

  • Andre T, Tougeron D, Piessen G, de la Fouchardiere C, Louvet C, Adenis A, Jary M, Tournigand C, Aparicio T, Desrame J, Lievre A, Garcia-Larnicol ML, Pudlarz T, Cohen R, Memmi S, Vernerey D, Henriques J, Lefevre JH, Svrcek M. Neoadjuvant Nivolumab Plus Ipilimumab and Adjuvant Nivolumab in Localized Deficient Mismatch Repair/Microsatellite Instability-High Gastric or Esophagogastric Junction Adenocarcinoma: The GERCOR NEONIPIGA Phase II Study. J Clin Oncol. 2023 Jan 10;41(2):255-265. doi: 10.1200/JCO.22.00686. Epub 2022 Aug 15.

    PubMed 35969830

  • Rha SY, Oh DY, Yanez P, Bai Y, Ryu MH, Lee J, Rivera F, Alves GV, Garrido M, Shiu KK, Fernandez MG, Li J, Lowery MA, Cil T, Cruz FM, Qin S, Luo S, Pan H, Wainberg ZA, Yin L, Bordia S, Bhagia P, Wyrwicz LS; KEYNOTE-859 investigators. Pembrolizumab plus chemotherapy versus placebo plus chemotherapy for HER2-negative advanced gastric cancer (KEYNOTE-859): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2023 Nov;24(11):1181-1195. doi: 10.1016/S1470-2045(23)00515-6. Epub 2023 Oct 21.

    PubMed 37875143

  • Qiu MZ, Oh DY, Kato K, Arkenau T, Tabernero J, Correa MC, Zimina AV, Bai Y, Shi J, Lee KW, Wang J, Poddubskaya E, Pan H, Rha SY, Zhang R, Hirano H, Spigel D, Yamaguchi K, Chao Y, Wyrwicz L, Disel U, Cid RP, Fornaro L, Evesque L, Wang H, Xu Y, Li J, Sheng T, Yang S, Li L, Moehler M, Xu RH; RATIONALE-305 Investigators. Tislelizumab plus chemotherapy versus placebo plus chemotherapy as first line treatment for advanced gastric or gastro-oesophageal junction adenocarcinoma: RATIONALE-305 randomised, double blind, phase 3 trial. BMJ. 2024 May 28;385:e078876. doi: 10.1136/bmj-2023-078876.

    PubMed 38806195

  • Xu J, Jiang H, Pan Y, Gu K, Cang S, Han L, Shu Y, Li J, Zhao J, Pan H, Luo S, Qin Y, Guo Q, Bai Y, Ling Y, Yang J, Yan Z, Yang L, Tang Y, He Y, Zhang L, Liang X, Niu Z, Zhang J, Mao Y, Guo Y, Peng B, Li Z, Liu Y, Wang Y, Zhou H; ORIENT-16 Investigators. Sintilimab Plus Chemotherapy for Unresectable Gastric or Gastroesophageal Junction Cancer: The ORIENT-16 Randomized Clinical Trial. JAMA. 2023 Dec 5;330(21):2064-2074. doi: 10.1001/jama.2023.19918.

    PubMed 38051328

  • Kang YK, Chen LT, Ryu MH, Oh DY, Oh SC, Chung HC, Lee KW, Omori T, Shitara K, Sakuramoto S, Chung IJ, Yamaguchi K, Kato K, Sym SJ, Kadowaki S, Tsuji K, Chen JS, Bai LY, Oh SY, Choda Y, Yasui H, Takeuchi K, Hirashima Y, Hagihara S, Boku N. Nivolumab plus chemotherapy versus placebo plus chemotherapy in patients with HER2-negative, untreated, unresectable advanced or recurrent gastric or gastro-oesophageal junction cancer (ATTRACTION-4): a randomised, multicentre, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Feb;23(2):234-247. doi: 10.1016/S1470-2045(21)00692-6. Epub 2022 Jan 11.

    PubMed 35030335

  • Janjigian YY, Shitara K, Moehler M, Garrido M, Salman P, Shen L, Wyrwicz L, Yamaguchi K, Skoczylas T, Campos Bragagnoli A, Liu T, Schenker M, Yanez P, Tehfe M, Kowalyszyn R, Karamouzis MV, Bruges R, Zander T, Pazo-Cid R, Hitre E, Feeney K, Cleary JM, Poulart V, Cullen D, Lei M, Xiao H, Kondo K, Li M, Ajani JA. First-line nivolumab plus chemotherapy versus chemotherapy alone for advanced gastric, gastro-oesophageal junction, and oesophageal adenocarcinoma (CheckMate 649): a randomised, open-label, phase 3 trial. Lancet. 2021 Jul 3;398(10294):27-40. doi: 10.1016/S0140-6736(21)00797-2. Epub 2021 Jun 5.

    PubMed 34102137

  • Wu X, Gu Z, Chen Y, Chen B, Chen W, Weng L, Liu X. Application of PD-1 Blockade in Cancer Immunotherapy. Comput Struct Biotechnol J. 2019 May 23;17:661-674. doi: 10.1016/j.csbj.2019.03.006. eCollection 2019.

    PubMed 31205619

  • Smyth EC, Nilsson M, Grabsch HI, van Grieken NC, Lordick F. Gastric cancer. Lancet. 2020 Aug 29;396(10251):635-648. doi: 10.1016/S0140-6736(20)31288-5.

    PubMed 32861308

  • Han B, Zheng R, Zeng H, Wang S, Sun K, Chen R, Li L, Wei W, He J. Cancer incidence and mortality in China, 2022. J Natl Cancer Cent. 2024 Feb 2;4(1):47-53. doi: 10.1016/j.jncc.2024.01.006. eCollection 2024 Mar.

    PubMed 39036382

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Adenocarcinoma, run by Chinese PLA General Hospital 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 8 inclusion and 4 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: finished, as of the sponsor's last update on 21 Oct 2026. 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tumor Regression Grading (TRG) (time frame: Approximately 1 week after surgery (when the pathology examination report available)). 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 NCT06798376, which also lists 16 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 Oct 2026.

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