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Stomach NeoplasmsPhase 2NeoRacingNCT05161572

Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer

A Phase 2 study testing Oxaliplatin, Tegafur-Gimeracil-Oteracil and Sintilimab in people with Stomach Neoplasms and Esophagogastric Junction Disorder, run by Fudan University at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

NeoRacing is a randomized phase II trial carried out at Fudan University Shanghai Cancer Center (FUSCC) in China. The study can be divided into the screening stage, treatment stage and follow-up stage. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Oxaliplatin, Tegafur-Gimeracil-Oteracil and Sintilimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
1 siteChina
Study dates
28 Sep 2021to 30 Sep 2022
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

  • Histopathologically confirmed gastric adenocarcinoma (G) or gastroesophageal junction adenocarcinoma (GEJ, excluding Siewert type I).
  • The clinical stage of the enrolled patients was cT3-4aN+M0 or cT4bNanyM0. Patients with a CY1 status but no other distant metastasis were allowed for patient recruitment. The clinical stage of CY1 patients is cT3-4aN+M1 (CY1 only) or cT4bNanyM1 (CY1 only) (the 8th AJCC staging system of GC).
  • The tumor was considered to be potentially resectable, which was verified by a multidisciplinary team including a surgical investigator.
  • At least one evaluable lesion on abdominal CT/MRI according to the RESIST 1.1 protocol is required.
  • An ECOG (Eastern Cooperative Oncology Group) performance status of 0-1.
  • The patient's physical state and organ function can tolerate the planned treatment of the study protocol, including perioperative chemotherapy with the SOX regimen and immunotherapy with PD-1 monoclonal antibody, preoperative concurrent chemoradiotherapy (45 Gy/25 fractions/S-1), and major abdominal surgery.
Show all 17Show fewer
  • The baseline laboratory examinations of the patients met the following criteria:
  • An adequate hematological function: an absolute neutrophil count (ANC) ≥ 1.5×109/L; a platelet count ≥ 100×109/L; a hemoglobin level ≥ 90 g/L.
  • Adequate liver function: total bilirubin ≤ 1.5×upper limit of normal (ULN); AST/ALT < 2.5×ULN; ALP ≤ 2.5×ULN; ALB ≥ 30 g/L.
  • Adequate renal function: serum creatinine ≤ 1.5 × ULN; creatinine clearance rate ≥ 60 ml/min.
  • Adequate coagulation function: INR/PT ≤ 1.5×ULN; APTT ≤ 1.5×ULN.
  • There was no serious concomitant disease, and the patient's life expectancy was more than 6 months.
  • Male or female. Age ≥ 18 years and ≤ 75 years.
  • Patients agreed to sign a written informed consent before recruitment.
  • Patients had good compliance with the study procedures, including laboratory examinations, auxiliary examinations and treatment.
  • The female patients should not be pregnant or breastfeeding.
  • The female patients agreed to take contraceptive measures during the treatment and within 120 days after the last dose of PD-1 mAb or 180 days after the last dose of chemotherapy or radiotherapy.

Who cannot join

  • Clinical or histopathological evidence of peritoneal seeding (P1) or distant metastasis (M1).
  • Patients who have previously received surgery, chemotherapy, radiotherapy or immunotherapy for gastric cancer.
  • Patients had a history of cancer in the five years before randomization except for squamous or basal cell carcinoma of the skin that had been effectively treated and superficial bladder cancer, cervical carcinoma in situ and breast cancer in situ that had been treated by surgery.
  • Pregnant or lactating females or planning to become pregnant or lactating.
  • History of allergy to any drugs involved in this study.
  • History of allogeneic stem cell transplantation or organ transplantation.
Show all 25Show fewer
  • Vaccinated with a live vaccine within 4 weeks before recruitment.
  • History of anti-PD-1, PD-L1, PD-L2 or any other specific T cell costimulation or checkpoint pathway targeted therapy.
  • History of using steroids (dose > 10 mg/d prednisone) or other systemic immunosuppressive therapy within 14 days before recruitment, except for patients treated with the following regimen: steroids used for hormone replacement (dose > 10 mg/d prednisone); local application of steroids with little systemic absorption; short-term (≤ 7 days) use of steroids to prevent allergy or vomiting.
  • Patients with weight loss of more than 20% within 2 months before recruitment.
  • Uncontrolled systemic diseases, including diabetes and hypertension.
  • Failure of important organs (heart, lung, liver, kidney, etc.).
  • Moderate or severe renal injury [creatinine clearance ≤ 50 ml/min (according to Cockroft \& Gault equation)] or SCR > ULN.
  • Dipyrimidine dehydrogenase (DPD) deficiency.
  • Patients with central nervous system (CNS) disorders, peripheral nervous system disorders or psychiatric diseases.
  • A cerebrovascular accident that occurred within 6 months before recruitment.
  • Patients with a known history of uncontrolled or symptomatic angina, uncontrolled arrhythmias and hypertension, congestive heart failure, cardiac infarction within 6 months prior to study recruitment, or cardiac insufficiency.
  • Patients who have the following history of pulmonary diseases: interstitial lung disease, noninfectious pneumonia, pulmonary fibrosis, acute lung disease, or pulmonary embolism.
  • Patients with severe gastrointestinal bleeding, gastrointestinal perforation, or gastrointestinal fistula and patients who cannot swallow to take the drug orally.
  • Patients with upper gastrointestinal obstruction, dysfunction or malabsorption syndrome that can affect the absorption of oral chemotherapy drugs.
  • Uncontrollable pleural effusion, pericardial effusion, or ascites that occurred within two weeks before recruitment.
  • Patients with a history of active autoimmune disease or refractory autoimmune disease.
  • Severe chronic or active infections requiring systemic antibiotics, antifungal or antiviral therapy, including tuberculosis and AIDS.
  • Known history of human immunodeficiency virus (HIV) infection.
  • Patients with untreated chronic hepatitis B or HBV-DNA exceeding 500 IU/ml or HCV-RNA positivity.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai

Other trials in China

About this study

Official title: A Randomized Phase II Trial of Perioperative Chemoimmunotherapy Verses Perioperative Chemoimmunotherapy Plus Preoperative Chemoradiation for Locally Advanced Gastric (G) or Gastroesophageal Junction (GEJ) Adenocarcinoma

NeoRacing is a randomized phase II trial carried out at Fudan University Shanghai Cancer Center (FUSCC) in China. The study can be divided into the screening stage, treatment stage and follow-up stage. The enrolled patients will receive perioperative SOX chemotherapy, PD-1 antibody (sintilimab) and radical surgery, with or without preoperative CRT. The patients were randomized by stratified permutated block randomization on a web-based system . The status of peritoneal cytological examination (CY0 vs. CY1) was the stratification factor. The study protocol was approved by the Ethics Committee of FUSCC. All patients provided written informed consent before recruitment. Monitoring will be carried out in this tri

Read the detailed description

Perioperative chemotherapy (ChT) and preoperative chemoradiation (CRT) are both the standard treatments for locally advanced gastric cancer (LAGC). CRT can achieve a higher pathological complete regression (pCR) rate, but whether this higher pCR rate can be transformed into a long-term survival benefit remains inconclusive. Therefore, relevant studies are in progress. On the other hand, immunotherapy has been established for the first-line treatment of advanced gastric cancer (AGC) and has been widely explored in the perioperative setting. The combination of chemotherapy/radiotherapy and immunotherapy may have a synergistic effect, which will lead to a better antitumor effect. The preliminary reports of ongoing studies show promising results, including a further improved pCR rate. However, the preferred treatment combination for LAGC is still not established. To solve this problem, we are carrying out this randomized phase II trial, which aims to evaluate the efficacy and safety of perioperative chemotherapy plus the use of PD-1 antibodies with or without preoperative chemoradiation for LAGC.

Perioperative chemotherapy (ChT) and preoperative chemoradiation (CRT) are both the standard treatments for locally advanced gastric cancer (LAGC). CRT can achieve a higher pathological complete regression (pCR) rate, but whether this higher pCR rate can be transformed into a long-term survival benefit remains inconclusive. Therefore, relevant studies are in progress. On the other hand, immunotherapy has been established for the first-line treatment of advanced gastric cancer (AGC) and has been widely explored in the perioperative setting. The combination of chemotherapy/radiotherapy and immunotherapy may have a synergistic effect, which will lead to a better antitumor effect. The preliminary reports of ongoing studies show promising results, including a further improved pCR rate. However, the preferred treatment combination for LAGC is still not established. To solve this problem, we are carrying out this randomized phase II trial, which aims to evaluate the efficacy and safety of perioperative chemotherapy plus the use of PD-1 antibodies with or without preoperative chemoradiation for LAGC.

The results of the NeoRacing study will provide important information concerning the application of PD-1 antibodies in LAGC patients during the preoperative setting. Meanwhile, the two treatment protocols will be compared in terms of efficacy and safety.

Being tested
Oxaliplatin, Tegafur-Gimeracil-Oteracil, Sintilimab, Concurrent chemoradiation, D2/R0 gastrectomy
Keywords
Locally advanced gastric cancer, Gastroesophageal junction adenocarcinoma, Perioperative chemotherapy, Preoperative chemoradiation, PD-1 antibody
Medical subject headings
Stomach Neoplasms, Adenocarcinoma

What participants receive

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

  • OxaliplatinDrug

    The SOX regimen consists of S-1 and oxaliplatin and is repeated every three weeks. Oxaliplatin will be administered intravenously at 130 mg/m2 on day 1.

  • Tegafur-Gimeracil-OteracilDrug

    The SOX regimen consists of S-1 and oxaliplatin and is repeated every three weeks. S-1 is administered orally at 40-60 mg twice a day for 14 consecutive days. Then, the patients will have a one-week rest period. The dose of S-1 is according to the body-surface area (BSA): patients with a BSA of less than 1.25 m2 receive 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 receive 100 mg daily; and those with a BSA of 1.5 m2 or more receive 120 mg daily.

  • SintilimabDrug

    The immunotherapy includes perioperative treatment and postoperative maintenance treatment. The PD-1 mAb used will be sintilimab, and the dose is 200 mg intravenously every three weeks. Regardless of which arm, the courses of immunotherapy that will be received by the enrolled patients are the same: 3 times preoperatively, 3 times postoperatively, and then maintained until one year after surgery.

  • Concurrent chemoradiationRadiation

    The radiotherapy (RT) consists of 45 Gy delivered in 25 fractions every five days per week for five weeks. The dose of concurrent ChT is 60 mg/m2 S-1 orally, oral tablets twice daily, days 1-5 of each week.

  • D2/R0 gastrectomyProcedure or surgery

    Gastrectomy with standard D2 lymphadenectomy is recommended. The type of gastrectomy performed depends on the location and extent of the primary lesion. For GEJ or upper third tumors, a 3 cm esophageal margin is recommended, and a total gastrectomy or esophagogastrectomy is performed. For middle third tumors, the gastric margin is recommended to be more than 5 cm, and a total gastrectomy is performed. For lower third tumors, a 2 cm duodenal margin is recommended, and a subtotal or total gastrectomy is performed. Billroth I or Roux-en-Y gastrojejunostomy is performed for distal gastrectomy patients. Roux-en-Y esophagojejunostomy is performed for patients receiving total gastrectomy.

Study groups in NCT05161572
Study groupRoleWhat they receive
Perioperative chemotherapy plus PD-1 antibody plus preoperative chemoradiotherapyExperimentalIn this arm, patients will receive preoperative chemoradiotherapy (45Gy/25Fractions), two cycles of SOX and three cycles of PD-1 antibody, followed by D2 surgery and three more cycles of SOX and PD-1 antibody. Then PD-1 antibody will be given until one year after surgery.
Receives: Drug: Oxaliplatin; Drug: Tegafur-Gimeracil-Oteracil; Drug: Sintilimab; Radiation: Concurrent chemoradiation; Procedure: D2/R0 gastrectomy
Perioperative chemotherapy plus PD-1 antibodyExperimentalIn this arm, patients will receive three cycles of SOX and PD-1 antibody, followed by D2 surgery and three more cycles of SOX and PD-1 antibody. Then PD-1 antibody will be given until one year after surgery.
Receives: Drug: Oxaliplatin; Drug: Tegafur-Gimeracil-Oteracil; Drug: Sintilimab; Procedure: D2/R0 gastrectomy

What is being measured

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

  1. Pathological complete regression (pCR) rate

    The primary endpoint is the pathological complete regression (pCR) rate: the proportion of patients who achieve pCR after preoperative therapy. Patients with a CY0 status at the time of enrollment should have no residual tumor cells in the primary lesion and in the dissected lymph nodes in the surgical specimens (ypT0N0M0). Patients with a CY1 status at the time of enrollment should reach both ypT0N0M0 and a CY0 status.

    Measured: 6 months after the enrollment of the last subject

Secondary outcomes (7)

  1. Pathological response rate (pRR)

    1. The pathological response rate (pRR) is defined as the proportion of patients with a pathological response. The tumor regression will be evaluated according to Ryan's tumor regression grading (TRG). The pathological response is defined as TRG0 and TRG1 of the primary lesion after preoperative therapy.

    Measured: 6 months after the enrollment of the last subject

  2. R0 resection rate

    The R0 resection rate is defined as the proportion of patients who achieve R0 resection. For patients with a CY0 status at the time of recruitment, the tumor should be completely removed, and no residual tumor cells within 1 mm of the resection margin should be confirmed by postoperative pathology. For patients with a CY1 status at the time of recruitment, an extra requirement is that CY0 should be confirmed by an peritoneal cytological examination.

    Measured: 6 months after the enrollment of the last subject

  3. Objective response rate (ORR)

    The Objective response rate (ORR) is defined as the proportion of patients with a complete response (CR) or a partial response (PR) to preoperative therapy. The ORR will be evaluated using the RESIST1.1 protocol.

    Measured: 6 months after the recruitment of the last subject.

  4. Event-free survival (EFS)

    The EFS will be calculated from the date of randomization to the date of any event or censoring. The event is defined as below: (1) locoregional recurrence; (2) peritoneal seeding; (3) distant metastasis; (4) death of any reason; (5) tumor progression according to RESIST 1.1.

    Measured: 36 months after the recruitment of the last subject.

  5. Overall survival (OS)

    The OS will be calculated from the date of randomization to the date of death or date of the last follow-up.

    Measured: 36 months after the recruitment of the last subject.

  6. Safety of perioperative therapy include chemo(radio)therapy and PD-1 antibody.

    Treatment related adverse events (TRAEs) of perioperative therapy will be graded and documented according to NCI-CTC AE v5.0 from the beginning of treatment to 28 days after the last date of treatment. Documentary will include the occurrence time, severity and time of duration. Common TRAEs include leukopenia, thrombocytopenia, anemia, ALT/AST increase, BUN/Scr increase, nausea, vomiting, diarrhea, appetite decrease, pruritus, rash, fatigue, malaise and pyrexia. Additional TRAEs of special interest include pneumonitis, interstitial lung disease, acute hepatitis, hyperthyroidism, autoimmune thyroiditis, thyroid disorder, hypopituitarism, colitis, maculopapular rash and epidermal capillary hyperplasia.

    Measured: One month after the last date of treatment

  7. Safety of surgery after preoperative therapy include chemo(radio)therapy and PD-1 antibody.

    Surgery related adverse events (SRAEs) refer to complications which happen during or one month after surgery. Severe complications after surgery will be documented and classified by Clavien-Dindo grading, such as abdominal or GI tract bleeding, anastomotic fistula, pancreatic fistula of grade B or above, and incision complications (infection, bleeding, rupture).

    Measured: During or one month after surgery

Timeline

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

  1. First posted17 Dec 2021
  2. Study start28 Sep 2021
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

Why it stopped: Difficult in recruiting participants

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
Masking
None (open label)
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05161572
Sponsor's protocol ID
FDRT- LAGCCS004
Acronym
NeoRacing
Status last verified
Jun 2025
First submitted
21 Nov 2021
Last updated
18 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Wang Y, Li Z, Shan F, Miao R, Xue K, Li Z, Gao C, Chen N, Gao X, Li S, Ji J. [Current status of diagnosis and treatment of early gastric cancer in China--Data from China Gastrointestinal Cancer Surgery Union]. Zhonghua Wei Chang Wai Ke Za Zhi. 2018 Feb 25;21(2):168-174. Chinese.

    PubMed 29492915

  • Joshi SS, Badgwell BD. Current treatment and recent progress in gastric cancer. CA Cancer J Clin. 2021 May;71(3):264-279. doi: 10.3322/caac.21657. Epub 2021 Feb 16.

    PubMed 33592120

  • van Hagen P, Hulshof MC, van Lanschot JJ, Steyerberg EW, van Berge Henegouwen MI, Wijnhoven BP, Richel DJ, Nieuwenhuijzen GA, Hospers GA, Bonenkamp JJ, Cuesta MA, Blaisse RJ, Busch OR, ten Kate FJ, Creemers GJ, Punt CJ, Plukker JT, Verheul HM, Spillenaar Bilgen EJ, van Dekken H, van der Sangen MJ, Rozema T, Biermann K, Beukema JC, Piet AH, van Rij CM, Reinders JG, Tilanus HW, van der Gaast A; CROSS Group. Preoperative chemoradiotherapy for esophageal or junctional cancer. N Engl J Med. 2012 May 31;366(22):2074-84. doi: 10.1056/NEJMoa1112088.

    PubMed 22646630

  • Stahl M, Walz MK, Stuschke M, Lehmann N, Meyer HJ, Riera-Knorrenschild J, Langer P, Engenhart-Cabillic R, Bitzer M, Konigsrainer A, Budach W, Wilke H. Phase III comparison of preoperative chemotherapy compared with chemoradiotherapy in patients with locally advanced adenocarcinoma of the esophagogastric junction. J Clin Oncol. 2009 Feb 20;27(6):851-6. doi: 10.1200/JCO.2008.17.0506. Epub 2009 Jan 12.

    PubMed 19139439

  • Leong T, Smithers BM, Haustermans K, Michael M, Gebski V, Miller D, Zalcberg J, Boussioutas A, Findlay M, O'Connell RL, Verghis J, Willis D, Kron T, Crain M, Murray WK, Lordick F, Swallow C, Darling G, Simes J, Wong R. TOPGEAR: A Randomized, Phase III Trial of Perioperative ECF Chemotherapy with or Without Preoperative Chemoradiation for Resectable Gastric Cancer: Interim Results from an International, Intergroup Trial of the AGITG, TROG, EORTC and CCTG. Ann Surg Oncol. 2017 Aug;24(8):2252-2258. doi: 10.1245/s10434-017-5830-6. Epub 2017 Mar 23.

    PubMed 28337660

  • Stahl M, Walz MK, Riera-Knorrenschild J, Stuschke M, Sandermann A, Bitzer M, Wilke H, Budach W. Preoperative chemotherapy versus chemoradiotherapy in locally advanced adenocarcinomas of the oesophagogastric junction (POET): Long-term results of a controlled randomised trial. Eur J Cancer. 2017 Aug;81:183-190. doi: 10.1016/j.ejca.2017.04.027.

    PubMed 28628843

  • Liu X, Jin J, Cai H, Huang H, Zhao G, Zhou Y, Wu J, Du C, Long Z, Fang Y, Ma M, Li G, Zhou M, Yin J, Zhu X, Zhu J, Sheng W, Huang D, Zhu H, Zhang Z, Lu Q, Xie L, Zhang Z, Wang Y. Study protocol of a randomized phase III trial of comparing preoperative chemoradiation with preoperative chemotherapy in patients with locally advanced gastric cancer or esophagogastric junction adenocarcinoma: PREACT. BMC Cancer. 2019 Jun 20;19(1):606. doi: 10.1186/s12885-019-5728-8.

    PubMed 31221115

  • Leong T, Smithers BM, Michael M, Gebski V, Boussioutas A, Miller D, Simes J, Zalcberg J, Haustermans K, Lordick F, Schuhmacher C, Swallow C, Darling G, Wong R. TOPGEAR: a randomised phase III trial of perioperative ECF chemotherapy versus preoperative chemoradiation plus perioperative ECF chemotherapy for resectable gastric cancer (an international, intergroup trial of the AGITG/TROG/EORTC/NCIC CTG). BMC Cancer. 2015 Jul 21;15:532. doi: 10.1186/s12885-015-1529-x.

    PubMed 26194186

  • Slagter AE, Jansen EPM, van Laarhoven HWM, van Sandick JW, van Grieken NCT, Sikorska K, Cats A, Muller-Timmermans P, Hulshof MCCM, Boot H, Los M, Beerepoot LV, Peters FPJ, Hospers GAP, van Etten B, Hartgrink HH, van Berge Henegouwen MI, Nieuwenhuijzen GAP, van Hillegersberg R, van der Peet DL, Grabsch HI, Verheij M. CRITICS-II: a multicentre randomised phase II trial of neo-adjuvant chemotherapy followed by surgery versus neo-adjuvant chemotherapy and subsequent chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery in resectable gastric cancer. BMC Cancer. 2018 Sep 10;18(1):877. doi: 10.1186/s12885-018-4770-2.

    PubMed 30200910

  • Liu X, Li G, Long Z, Yin J, Zhu X, Sheng W, Huang D, Zhu H, Zhang Z, Cai H, Huang H, Zhao G, Zhou Y, Zhang Z, Wang Y. Phase II trial of preoperative chemoradiation plus perioperative SOX chemotherapy in patients with locally advanced gastric cancer. J Surg Oncol. 2018 Mar;117(4):692-698. doi: 10.1002/jso.24917. Epub 2017 Nov 30.

    PubMed 29194623

  • Zhang X, Liang H, Li Z, Xue Y, Wang Y, Zhou Z, Yu J, Bu Z, Chen L, Du Y, Wang X, Wu A, Li G, Su X, Xiao G, Cui M, Wu D, Chen L, Wu X, Zhou Y, Zhang L, Dang C, He Y, Zhang Z, Sun Y, Li Y, Chen H, Bai Y, Qi C, Yu P, Zhu G, Suo J, Jia B, Li L, Huang C, Li F, Ye Y, Xu H, Wang X, Yuan Y, E JY, Ying X, Yao C, Shen L, Ji J; RESOLVE study group. Perioperative or postoperative adjuvant oxaliplatin with S-1 versus adjuvant oxaliplatin with capecitabine in patients with locally advanced gastric or gastro-oesophageal junction adenocarcinoma undergoing D2 gastrectomy (RESOLVE): an open-label, superiority and non-inferiority, phase 3 randomised controlled trial. Lancet Oncol. 2021 Aug;22(8):1081-1092. doi: 10.1016/S1470-2045(21)00297-7. Epub 2021 Jul 9.

    PubMed 34252374

  • Zhang L, Mai W, Jiang W, Geng Q. Sintilimab: A Promising Anti-Tumor PD-1 Antibody. Front Oncol. 2020 Nov 26;10:594558. doi: 10.3389/fonc.2020.594558. eCollection 2020.

    PubMed 33324564

  • Japanese Gastric Cancer Association. Japanese classification of gastric carcinoma: 3rd English edition. Gastric Cancer. 2011 Jun;14(2):101-12. doi: 10.1007/s10120-011-0041-5. No abstract available.

    PubMed 21573743

  • Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2014 (ver. 4). Gastric Cancer. 2017 Jan;20(1):1-19. doi: 10.1007/s10120-016-0622-4. Epub 2016 Jun 24. No abstract available.

    PubMed 27342689

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Oxaliplatin, Tegafur-Gimeracil-Oteracil and Sintilimab in people with Stomach Neoplasms and Esophagogastric Junction Disorder, run by Fudan University 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 17 inclusion and 25 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: stopped early, as of the sponsor's last update on 18 Jun 2025. 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?

The study was stopped early (reason given: Difficult in recruiting participants). Results are not available in the source record.

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?

Pathological complete regression (pCR) rate (time frame: 6 months after the enrollment of the last subject). 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 NCT05161572, which also lists 17 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 18 Jun 2025.

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