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Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction CancerPhase 2/3NCT05149807

Clinical Study of SHR-1701 Plus Chemotherapy as Perioperative Treatment in Subjects With Gastric Cancer

A Phase 2/3 study testing SHR-1701 injection in people with Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 20 sites in China.

Terminated

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

Official record
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Trial summary

This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHR-1701 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
20 sitesChina
Study dates
26 Jan 2022to 3 Apr 2024
Phase
Phase 2/3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Pathologically diagnosed with GC or GEJC, histologically confirmed to be adenocarcinoma, and have no previous anti-tumor treatments for GC or GEJC.
  • Aged 18 or above, male or female.
  • Be suitable for (investigator's assessment) and planning to undergo neoadjuvant therapy + radical surgery with curative intent before entering into the study.
  • locally advanced Gastric Cancer or Gastroesophageal Junction Cancer confirmed by investigator.
  • Be able to provide tumor tissue blocks.
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1.
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  • Life expectancy of ≥ 6 months.
  • Have adequate organ and bone marrow functions.
  • Women without childbearing potential refer to post-menopausal women, or women who underwent bilateral oophorectomy with medical records. Male subjects and female subjects of childbearing potential must agree to take a medically approved contraceptive measure (refer to Appendix 4) during the study, within 3 months after the last dose of investigational product (SHR-1701), and within 9 months after the last dose of chemotherapy agents (S-1 and oxaliplatin); have a negative serum pregnancy test result within 3 days prior to the start of study treatment and not be breastfeeding.
  • Subjects must agree and have signed the informed consent form, be willing and able to follow the scheduled visits, study treatment, laboratory tests, and other study procedures.

Who cannot join

  • Have known squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer, or adenocarcinoma mixed with gastric cancer of other histological types.
  • Have unresectable factors, including unresectable tumors or contraindications to surgery or refusal of surgery.
  • Have more than 20% weight loss within 2 months prior to enrollment or randomization.
  • Have previously received some treatments or medications including anti-tumor treatments.
  • Diagnosed with other malignant tumors within 5 years prior to enrollment.
  • Have any active, known, or suspected autoimmune disease.
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  • Have clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment or randomization; have gastrointestinal perforation and/or gastrointestinal fistula within 6 months prior to enrollment or randomization; have arterial/venous thrombotic events within 6 months prior to enrollment or randomization.
  • Have major vascular disease within 6 months prior to enrollment or randomization.
  • Have severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.
  • Have intestinal obstruction and/or clinical signs or symptoms of gastrointestinal obstruction within 6 months prior to enrollment or randomization.
  • Have interstitial lung disease, non-infectious pneumonitis, or uncontrolled systemic disease.
  • Have known allergies to the study drug or their excipients; have severe allergic reactions to other monoclonal antibodies.
  • Have HIV infection or known AIDS, active untreated hepatitis or co-infection with hepatitis B and C.
  • Have uncontrolled cardiac symptoms or disease:
  • Have received systemic antibiotics for ≥ 7 days within 4 weeks prior to enrollment or randomization, or have unexplained fever > 38.5 °C during screening or before the first dose.
  • Have known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  • Have been screened for other clinical studies but failed the screening because PD-L1 expression did not meet the inclusion criteria or met the exclusion criteria; have participated in clinical studies of any other drugs, less than 4 weeks or 5 half-lives of the drug between the last dose of these study treatments and enrollment/randomization for this study (whichever is longer).
  • Have a known history of psychotropic substance abuse or drug abuse.
  • Have other severe physical or psychiatric disorders or laboratory abnormalities, which may increase the risk of participation in this study or interfere with the study results, or deemed unsuitable by the investigator.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Anyang Cancer Hospital

    Anyang, Henan, 455000

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui, 233004

  • Sichuan Cancer Hospital & Institute

    Chengdu, Sichuan, 610042

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

  • Southern Medical University NanFang Hospital

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510000

  • The Second Affiliated Hospital Of Anhui Medical University

    Hefei, Anhui, 230601

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang, Henan, 471003

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200000

  • Liaoning Cancer Hospital&Institute

    Shenyang, Liaoning, 110801

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050000

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Hubei Cancer Hospital

    Wuhan, Hubei, 430079

  • The Second Affiliated Hospital of Air Force Military University Tangdu Hospital

    Xi’an, Shanxi, 7100038

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710061

  • Xingtai People's Hospital

    Xingtai, Hebei, 054031

  • Subei people's Hospital of Jiangsu Province

    Yangzhou, Jiangsu, 225001

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Multi-Center Phase II/III Clinical Study of PD-L1 Antibody/TGF-βRII (SHR-1701) Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin Versus Placebo Plus Tegafur Gimeracil Oteracil Potassium and Oxaliplatin as Perioperative Treatment in Subjects With Resectable Gastric Cancer or Gastroesophageal Junction Cancer

This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin mainly by the endpoint of pCR rate.

Stage II is a randomized, double-blind, multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC. A total of 846 treatment naïve subjects will be enrolled, and primary endpoint of this stage is Independent Review Committee (IRC)-assessed EFS.

Being tested
SHR-1701 injection, Placebo

What participants receive

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

  • SHR-1701 injectionDrug

    SHR-1701 injection Tegafur Gimeracil Oteracil Potassium Oxaliplatin

  • PlaceboDrug

    Placebo Tegafur Gimeracil Oteracil Potassium Oxaliplatin

Study groups in NCT05149807
Study groupRoleWhat they receive
SHR-1701 + Tegafur Gimeracil Oteracil Potassium and OxaliplatinExperimentalNot described
Receives: Drug: SHR-1701 injection
Placebo + Tegafur Gimeracil Oteracil Potassium and OxaliplatinPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Phase II : Pathological Complete Response pCR rate.

    pCR rate is defined as the proportion of subjects whose specimens (including primary lesion and lymph nodes) obtained during GC or GEJC radical surgery are pathologically assessed to be free of residual live tumor cells after neoadjuvant therapy.

    Measured: Up to approximately 23 months

  2. Phase III : Event-free Survival (EFS)

    EFS is defined as time from randomization to PD or death (whichever occurs first), detailed that tumor progression/recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.

    Measured: Up to approximately 57 months

Secondary outcomes (7)

  1. Disease-free Survival (DFS).

    DFS is defined as time from R0 resection to PD or death (whichever occurs first), detailed that tumor recurrence or new lesion confirmed by RECIST v1.1 criteria or death due to any cause.

    Measured: Up to approximately 57 months

  2. Preoperative Objective Response Rate (ORR).

    Preoperative ORR is defined as proportion of enrolled or randomized subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) according to RECIST v1.1 criteria during neoadjuvant therapy period.

    Measured: Up to approximately 57 months

  3. Major pathological response (MPR) rates.

    MPR rate is defined as proportion of subjects whose primary lesion specimens obtained during GC or GEJC radical surgery are pathologically assessed to have < 10% residual live tumor cells relative to the primary tumor tissue (Becker grade 1a or 1b) after neoadjuvant therapy.

    Measured: Up to approximately 23 months

  4. R0 resection rate

    R0 resection rate is defined as proportion of subjects without gross or microscopic residual tumor (negative margin) after neoadjuvant therapy and GC or GEJC radical surgery.

    Measured: Up to approximately 23 months

  5. Overall Survival (OS).

    OS is defined as time from randomization to death of any cause.

    Measured: Up to approximately 57 months

  6. Percentage of Participants Who Experience One or More Adverse Events (AEs).

    An AE is defined as any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The percentage of participants who experience at least one AE will be presented.

    Measured: Up to approximately 57 months

  7. 30-day postoperative mortality.

    30-day postoperative mortality is defined as proportion of subjects who died due to any reason within 30 days after radical surgery for GC.

    Measured: Up to approximately 24 months

Timeline

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

  1. First posted8 Dec 2021
  2. Study start26 Jan 2022
  3. Primary completion3 Apr 2024
  4. Study completion3 Apr 2024

Why it stopped: R\&d strategy adjustment

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a multi-center phase II/III clinical study consisting of two stages: Stage I is a single-arm open-label phase II study to preliminarily explore the efficacy and safety of SHR-1701 plus S-1 and oxaliplatin; Stage II is a randomized, double-blind, multi-center phase III study of SHR-1701 plus S-1 and oxaliplatin versus placebo plus S-1 and oxaliplatin as perioperative treatment in subjects with resectable GC or GEJC.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05149807
Sponsor's protocol ID
SHR-1701-III-308
Status last verified
Jul 2024
First submitted
9 Nov 2021
Last updated
20 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SHR-1701 injection in people with Perioperative Treatment in Subjects With Locally Advanced Resectable Gastric Cancer or Gastroesophageal Junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 20 sites 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 10 inclusion and 19 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 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined 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.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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: R\&d strategy adjustment). 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?

Phase II : Pathological Complete Response pCR rate. (time frame: Up to approximately 23 months). 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 NCT05149807.

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 20 Aug 2025.

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Clinical Trial NCT05149807 | AzTrials