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Gastric CancerPhase 3NCT03745170

Efficacy and Safety Evaluation of Sintilimab or Placebo in Combination With XELOX as First Line Treatment in Patients With Gastric Cancer

A Phase 3 study testing Sintilimab, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Innovent Biologics (Suzhou) Co. Ltd. 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 purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Gastric Cancer
What is being tested?
Sintilimab, Oxaliplatin and Capecitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
650 participants
Where
1 siteChina
Study dates
19 Dec 2018to 21 Oct 2022
Phase
Phase 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

  • Has histologically confirmed diagnosis of unresectable locally advanced,recurrent or metastatic gastric or GEJ adenocarcinoma.
  • Male or Female at least 18 years of age
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Did not receive neoadjuvant or adjuvant treatment (chemotherapy,radiotherapy, or both) for their disease within the last 6 months
  • Must agree to provide tumor tissue sample, either from a previous surgeryor biopsy , within 6 months or fresh, prior to the start of treatment in this study and Has a PD-L1 status determined by immunohistochemistry (IHC) at a central laboratory
  • Has measurable or non-measurable (but assessable) disease as defined by RECIST 1.1 as determined by investigator assessment.
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  • Has adequate organ function.
  • Expected survival>=12 weeks.
  • Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test at the timing of enrollment.
  • Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication.

Who cannot join

  • Suspicious active bleeding or obstruction phenomenon and Has difficulty in swallow tablets and food
  • HER2-positive status
  • Has had previous therapy for unresectable locally advanced, recurrent or metastatic gastric/GEJ cancer
  • Has received prior therapy with a dose of cisplatin>=300 mg/m-^2
  • Has grade ≥ 2 peripheral sensory neuropathy
  • Known DPD enzyme deficiency status (>=grade 3 mucosal toxicity in previous fluorouracil treatment)
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  • Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
  • Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Has had major surgery (craniotomy, thoracotomy or laparotomy) within 4 weeks prior to first dose of study medication, or anticipation of the need for major surgery during the course of study treatment
  • Known symptomatic central nervous system (CNS) metastasis and/or carcinomatous meningitis. Subjects received prior treatment and have stable disease more than 4 weeks from first dose of study medication.
  • Clinical significant ascites, including which can be detected in percussion, had been ever drained or still need to be controlled currently.
  • Bilateral moderate pleural effusion, or a large amount of pleural effusion on one side, or has caused respiratory dysfunction requiring drainage.
  • Bone metastasis with risk of paraplegia.
  • Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll) .
  • Known primary immunodeficiency.
  • Known active tuberculosis.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
  • Known>=grade 3 allergy or hypersensitivity to oxaliplatin,capecitabine or any monoclonal antibodies.
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).
  • Active or poorly controlled severe infection.
  • Symptomatic congestive heart failure (New York Heart Association grade II-IV) or symptomatic, poorly controlled arrhythmia.
  • Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100mmHg) with standard treatment .
  • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment.
  • Malnutrition requiring intravenous nutrition, subjects with malnutrition correction≥4 weeks are permitted to enroll.
  • Prior deep vein thrombosis, pulmonary embolism or any other severe thromboembolism events (implanted port or catheter caused thrombosis, or superficial vein thrombosis are not considered as severe thromboembolism) within 3 months before enrollment.
  • History of uncontrolled metabolic disorder, non-malignant organ or systemic disease or secondary carcinomatous reaction, with high medical risk and/or uncertainty of life expectancy evaluation.
  • With hepatic encephalopathy, hepatorenal syndrome or hepatic cirrhosis of Child-Pugh grade B or higher.
  • History of intestinal obstruction or the following diseases: inflammatory bowel disease or extensive bowel resection (partial colonic resection or extensive small bowel resection, concomitant with chronic diarrhea), Crohn's disease, ulcerative colitis.
  • Known acute or chronic active hepatitis B infection (positive HBsAg and HBV DNA ≥ 200 IU/mL or ≥ 10^3 copies/mL positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection.
  • History of gastrointestinal perforation and /or fistula within 6 months before enrollment.
  • Subjects with interstitial lung disease requiring steroids therapy.
  • Other primary malignancy, with the exception of:
  • Malignancy which achieved complete response for at least 2 years before enrollment and do not need other treatment during study period;Curative malignancy, without active disease in the last 5 years and with very low recurrence risk;
  • Non-melanoma skin cancer or malignant freckle-like nevus with adequate treatment and no evidence of recurrence ;
  • Adequately treated in-situ carcinoma.
  • Women who are pregnant or nursing.
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Fifth Medical Center,Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100000

Other trials in China

About this study

The purpose of this study is to estimate overall survival of Sintilimab+ oxaliplatin + capecitabine and placebo+ oxaliplatin + capecitabine, as first-line treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.

Conditions
Gastric Cancer
Being tested
Sintilimab, Oxaliplatin, Capecitabine, placebo
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • SintilimabDrug

    Also called IBI308

    Weight<60Kg: 3mg/kg Q3W Weignt>=60Kg:200 mg Q3W on Day 1 by IV infusion

  • OxaliplatinDrug

    130 mg/m^2 Q3W on Day 1 by IV infusion

  • CapecitabineDrug

    1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

  • placeboDrug

    Weight<60Kg: 3mg/kg Q3W Weignt>=60Kg:200 mg Q3W on Day 1 by IV infusion

Study groups in NCT03745170
Study groupRoleWhat they receive
Sintilimab+ Oxaliplatin +capecitabineExperimentalNot described
Receives: Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine
placebo +Oxaliplatin + CapecitabineActive comparatorNot described
Receives: Drug: Oxaliplatin; Drug: Capecitabine; Drug: placebo

What is being measured

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

  1. Overall survival (OS)

    Overall survival (OS)of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants;Overall survival(OS) of Sintilimab + oxaliplatin + capecitabine versus placebo+ oxaliplatin + capecitabine in participants with programmed cell death ligand 1 (PD-L1) expressing tumors (CPS>=10)

    Measured: Approximately 40 months after the first participant is randomized

Secondary outcomes (5)

  1. Progression Free Survivla (PFS)

    Progression Free Survivla (PFS) of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants and PD-L1 expression participants(CPS>=10)

    Measured: Approximately 40 months after the first participant is randomized

  2. Duration of Response (DoR)

    Duration of Response (DoR) of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants and PD-L1 expression participants(CPS>=10)

    Measured: Approximately 40 months after the first participant is randomized

  3. Objective Response Rate (ORR)

    Objective Response Rate (ORR) of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus placebo+oxaliplatin + fluoropyrimidine in all randomized participants and PD-L1 expression participants(CPS>=10) per RESIST v1,1

    Measured: Approximately 40 months after the first participant is randomized

  4. Disease Control Rate (DCR)

    Disease Control Rate (DCR) of Sintilimab + oxaliplatin + capecitabine versus placebo+ oxaliplatin + capecitabine in in all randomized participants . and PD-L1 expression participants(CPS>=10)

    Measured: Approximately 40 months after the first participant is randomized

  5. Number of participants experiencing clinical and laboratory adverse events (AEs)

    Safety of Sintilimab in combination with oxaliplatin + fluoropyrimidine versus oxaliplatin + fluoropyrimidine in all randomized participants and PD-L1 expression participants(CPS>=10)

    Measured: Approximately 40 months after the first participant is randomized

Timeline

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

  1. First posted19 Nov 2018
  2. Study start19 Dec 2018
  3. Primary completion20 Jun 2021
  4. Study completion21 Oct 2022

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
Double blind
Who is masked
Participant, Investigator
Enrolment
650 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03745170
Sponsor's protocol ID
CIBI308E301
Status last verified
Feb 2023
First submitted
14 Nov 2018
Last updated
1 Mar 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu H, Shu W, Ding Y, Li Q, Li N, Wang Q, Chen Y, Han Y, Huang D, Jiang H. The immune signatures predict gastric/gastroesophageal junction cancer response to first-line anti-PD-1 blockade or chemotherapy. BMC Cancer. 2025 Aug 25;25(1):1369. doi: 10.1186/s12885-025-14805-6.

    PubMed 40851062

  • Li W, Wan L. Cost-utility of sintilimab plus chemotherapy vs chemotherapy as first-line treatment of advanced gastric or gastroesophageal junction cancer in China. Expert Rev Pharmacoecon Outcomes Res. 2024 Jun;24(5):671-678. doi: 10.1080/14737167.2024.2341859. Epub 2024 Apr 11.

    PubMed 38594905

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sintilimab, Oxaliplatin and Capecitabine in people with Gastric Cancer, run by Innovent Biologics (Suzhou) 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 10 inclusion and 39 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 1 Mar 2023. 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 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 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?

Overall survival (OS) (time frame: Approximately 40 months after the first participant is randomized). 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 NCT03745170, which also lists 3 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 1 Mar 2023.

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