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Gastric or Gastroesophageal Junction CancerPhase 3NCT04950322

A Trial of SHR1701 Plus Chemotherapy in Patients With Gastric or Gastroesophageal Cancer

A Phase 3 study testing SHR-1701、CAPOX in people with Gastric or Gastroesophageal Junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SHR-1701、CAPOX
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
737 participants
Where
1 siteChina
Study dates
6 Dec 2021to 1 Oct 2025
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 confirmed diagnosis of locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ)adenocarcinoma.
  • HER2 overexpression or amplification negative.
  • Female or male, 18 years of age or above.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1.
  • Patients who are willing and able to provide the signed informed consent form, willing and able to comply with all the scheduled visits, study treatment, laboratory tests, and other study procedures.

Who cannot join

  • Squamous cell carcinoma, undifferentiated carcinoma, or other histological types of gastric cancer.
  • Presence of inadequately treated CNS metastases, or uncontrolled or symptomatic active CNS metastases ，leptomeningeal disease, and/or rapid progression.
  • Presence of uncontrolled pleural effusion or ascites despite puncture drainage within 14 days prior to randomization.
  • More than 20% weight loss within 2 months prior to randomization.
  • Diagnosed with other malignant tumors within 5 years prior to enrollment.
  • Presence of any active, known or suspected autoimmune disease.
  • Prior treatment with TGF-β inhibitor, anti-PD-1/PD-L1 antibodies, anti-PD-L2 antibodies, anti-CD137 antibodies, anti-CTLA-4 antibodies, or other drugs/antibodies.
  • Severe, unhealed, or dehisced wounds and active ulcers or untreated fractures.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 1000000

Other trials in China

About this study

Official title: A Randomized, Double-Blind, Multi-Center, Phase III Clinical Study of SHR-1701 Plus Chemotherapy Versus Placebo Plus Chemotherapy as Treatment in Patients With Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer

This study is a randomized, Double-Blind, multi-center Phase III clinical study, aimed to evaluate the efficacy and safety of SHR1701 combined with chemotherapy in the treatment of Previously Untreated, Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer. For Part 1 study，the tolerability of SHR-1701 will be evaluated and determine the recommended dose for Part 2.For Part 2 study, all enrolled patients will be randomized to 2 groups and continuously treated until the end criteria of treatment was met.

Being tested
SHR-1701、CAPOX, Placebo、CAPOX

What participants receive

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

  • SHR-1701、CAPOXDrug

    SHR-1701 with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

  • Placebo、CAPOXDrug

    Placebo with CAPOX (CAPOX:Oxaliplatin,Capecitabine)

Study groups in NCT04950322
Study groupRoleWhat they receive
Treatment group AExperimentalNot described
Receives: Drug: SHR-1701、CAPOX
Treatment group BPlacebo comparatorNot described
Receives: Drug: Placebo、CAPOX

What is being measured

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

  1. AEs and SAEs in part 1 study

    The number and proportion of subjects with dose limiting toxicity. The safety endpoints, including incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

    Measured: up to 2 years

  2. Overall survival in subjects with PD-L1 CPS ≥ 5 in part 2 study

    Measured: up to 3 years

  3. OS in all subjects in part 2 study

    Overall survival (OS)

    Measured: up to 3 years

Secondary outcomes (17)

  1. ORR in part 1 study

    Objective response rate (ORR) as assessed by the investigator per RECIST 1.1

    Measured: up to 2 years

  2. DCR in part 1 study

    Disease control rate (DCR) as assessed by the investigator per RECIST 1.1

    Measured: up to 2 years

  3. PFS in part 1 study

    Progression free survival (PFS) as assessed by the investigator per RECIST 1.1

    Measured: up to 2 years

  4. DoR in part 1 study

    Duration of response (DoR) as assessed by the investigator per RECIST 1.1

    Measured: up to 2 years

  5. OS in part 1 study

    Overall survival (OS)

    Measured: up to 3 years

  6. PFS in part 2 study

    PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

    Measured: up to 3 years

  7. ORR in part 2 study

    ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

    Measured: up to 2 years

  8. DCR in part 2 study

    DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

    Measured: up to 2 years

  9. DoR in part2 study

    DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by BICR per RECIST 1.1

    Measured: up to 2 years

  10. PFS in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator as per RECIST 1.1

    Measured: up to 2 years

  11. ORR in part 2 study

    ORR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

    Measured: up to 2 years

  12. DCR in part 2 study

    DCR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

    Measured: up to 2 years

  13. DoR in part 2 study

    DoR in subjects with PD-L1 CPS ≥5 and in all subjects as assessed by investigator per RECIST 1.1

    Measured: up to 2 years

  14. AEs and SAEs in part 2 study

    Safety endpoints, including incidence and severity of AEs and SAEs as per NCI-CTCAE v5.0 criteria

    Measured: up to 2 years

  15. EORTC QLQ-C30 score

    Measured: up to 2 years

  16. EORTC QLQ-STO22 score

    Measured: up to 2 years

  17. EQ-5D-5L score

    Measured: up to 2 years

Timeline

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

  1. First posted6 Jul 2021
  2. Study start6 Dec 2021
  3. Primary completion20 May 2024
  4. Study completion1 Oct 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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
737 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04950322
Sponsor's protocol ID
SHR-1701-III-307
Status last verified
Mar 2025
First submitted
29 Jun 2021
Last updated
30 Mar 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Peng Z, Wang J, Zhang Y, Li H, Zhao Q, Zhu X, Wei S, Chen Y, Yang W, Yao J, Zhang M, Xie L, Zhang X, Zhao P, Hu C, Zhang J, Gu K, Bai J, Chen Y, Zhang Z, Zhang J, Wang J, Niu Z, Pan Y, Liu Z, Deng Y, Wang Z, Wang W, Han H, Shen L. First-Line Retlirafusp Alfa Plus Chemotherapy for Human Epidermal Growth Factor Receptor 2-Negative Gastric or Gastroesophageal Junction Adenocarcinoma: A Randomized, Double-Blind, Phase III Study (RELIGHT). J Clin Oncol. 2026 Nov;44(31):3015-3025. doi: 10.1200/JCO-25-02933. Epub 2026 Sep 24.

    PubMed 42784781

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SHR-1701、CAPOX in people with Gastric or Gastroesophageal Junction Cancer, run by Suzhou Suncadia Biopharmaceuticals Co., Ltd. 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 30 Mar 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. 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 phase mean?

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?

This study is still under way. Results are not available in the source record yet.

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?

AEs and SAEs in part 1 study (time frame: up to 2 years). The study lists 3 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 NCT04950322, which also lists 1 linked publication.

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 30 Mar 2025.

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