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CompletedNCT03941873Updated Oct 26, 2024Results posted

A Study to Investigate Sitravatinib as Monotherapy and in Combination With Tislelizumab in Participants With Unresectable Locally Advanced or Metastatic Hepatocellular Carcinoma or Gastric/Gastroesophageal Junction Cancer

A Phase 1/2 interventional study of Sitravatinib and Tislelizumab in Carcinoma, Hepatocellular and Gastric/Gastroesophageal Junction Cancer, sponsored by BeiGene. Completed at 18 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-10-26.

Sponsored by BeiGene · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
111
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study was to evaluate the safety, tolerability, pharmacokinetics and preliminary antitumor activity of sitravatinib as monotherapy and in combination with tislelizumab in participants with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC) or gastric/gastroesophageal junction (G/GEJ) cancer.

Read the detailed description

This was an open-label, multicenter Phase 1/2 clinical study for participants with histologically or cytologically confirmed unresectable locally advanced or metastatic HCC or G/GEJ cancer. All participants received study treatment (s) until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor.

02

Conditions studied

  • Carcinoma, Hepatocellular
  • Gastric/Gastroesophageal Junction Cancer

Keywords

  • Carcinoma
  • HCC
  • G/GEJ Cancer
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's enrollment of 111 is above the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

BeiGene is the lead sponsor of 122 studies on the registry; 3 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 31 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

  • Histologically or cytologically confirmed, unresectable, locally advanced, or metastatic HCC/gastric cancer/GEJ cancer
  • Able to provide written informed consent and can understand and agree to comply with the requirements of the study and the schedule of assessments
  • Age ≥ 18 years on the day of signing the informed consent form (or the legal age of consent in the jurisdiction in which the study is taking place)
  • Adequate organ function
  • Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and ≥ 120 days after the last dose of study drug(s), and have a negative serum pregnancy test ≤ 7 days of first dose of study drug(s)
  • Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study and for ≥ 120 days after the last dose of study drug(s)
  • Failed current standard-of-care treatment, or standard-of-care treatment is considered not appropriate at present

Key Exclusion Criteria:

  • Active leptomeningeal disease or uncontrolled brain metastasis
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Any active malignancy ≤ 2 years before first dose of study drug(s)
  • History of interstitial lung disease, noninfectious pneumonitis or uncontrolled diseases including pulmonary fibrosis or acute lung diseases
  • Severe chronic or active infections (including tuberculosis infection) requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days prior to first dose of study drug(s)
  • Known history of human immunodeficiency virus (HIV) infection
  • Untreated chronic hepatitis B or chronic hepatitis B virus (HBV) carriers.
  • Any major surgical procedure requiring general anesthesia ≤ 28 days before the first dose of study drug(s)
  • Prior allogeneic stem cell transplantation or organ transplantation
  • Inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg)
  • Bleeding or thrombotic disorders or use of anticoagulants such as warfarin or similar agents requiring therapeutic international normalized ratio (INR) monitoring
  • Any systemic chemotherapy within 28 days of the first dose of study drug(s) or hormone therapy, targeted therapy, or any investigational therapies
  • Toxicities (as a result of prior anticancer therapy) that have not recovered to baseline or stabilized, except for adverse events not considered a likely safety risk (eg, alopecia, neuropathy, and specific laboratory abnormalities)
  • Inability to swallow capsules or disease significantly affecting gastrointestinal function
  • Pregnant or breastfeeding woman

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    Sitravatinib Monotherapy: 80 mg

    Sitravatinib 80 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

    Drug: Sitravatinib

  • Experimental
    Sitravatinib Monotherapy: 120 mg

    Sitravatinib 120 mg orally once daily in 21-day cycles in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

    Drug: Sitravatinib

  • Experimental
    Sitravatinib 80 mg + Tislelizumab

    Sitravatinib 80 mg orally once daily in 21-day cycles with tislelizumab 200 mg intravenously (IV) once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

    Drug: Sitravatinib · Drug: Tislelizumab

  • Experimental
    Sitravatinib 120 mg + Tislelizumab

    Sitravatinib 120 mg orally once daily in 21-day cycles with tislelizumab 200 mg IV once every 3 weeks in participants with unresectable locally advanced or metastatic HCC or G/GEJ cancer

    Drug: Sitravatinib · Drug: Tislelizumab

Interventions

  • DrugSitravatinib

    Administered orally as a capsule

    Also known as: MGCD516

  • DrugTislelizumab

    Administered intravenously

    Also known as: BGB-A317, Tevimbra

06

What researchers measure

Primary outcomes

  1. Number of Participants With Adverse Events

    Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).

    Time frame: Up to approximately 4 years and 1 month

  2. Objective Response Rate (ORR)

    ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

    Time frame: Up to approximately 4 years and 1 month

Secondary outcomes

  1. Duration of Response (DOR)

    DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

    Time frame: Up to approximately 4 years and 1 month

  2. Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with BOR as CR, PR, or stable disease (SD) assessed by investigator per RECIST v1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

    Time frame: Up to approximately 4 years and 1 month

  3. Progression-free Survival (PFS)

    PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. Safety analysis set is presented by indication group, as prespecified in the statistical analysis plan.

    Time frame: Up to approximately 4 years and 1 month

  4. Maximum Plasma Concentration (Cmax) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21) (21 days in each cycle)

  5. Time to Maximum Plasma Concentration (Tmax) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  6. Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  7. Clearance After Oral Administration (CL/F) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  8. Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  9. Observed Accumulation Ratio (Ro) for AUC(0-tau) for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  10. Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib

    Time frame: Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)

  11. Plasma Concentrations of Sitravatinib

    Time frame: Predose and 6 hours postdose in Cycle 5 Day 1 (21 days in each cycle)

07

Results

Posted Oct 18, 2024

Participant flow

This study was conducted at multiple sites in China.

Participant flow — Overall Study
MilestoneSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
Started324381
Completed1318
Not completed221273
Withdrew: Death012253
Withdrew: Withdrawal by subject1105
Withdrew: Lost to follow-up1200
Withdrew: Sponsor decision06015

Outcome measures

PrimaryNumber of Participants With Adverse Events

Number of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) per National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v5.0), including relevant physical examination, electrocardiograms, and laboratory assessments. Safety analysis set is presented by dose, as prespecified in the statistical analysis plan (SAP).

Time frame:
Up to approximately 4 years and 1 month
Reported as:
Count of participants · Participants
Number of Participants With Adverse Events
ParticipantsSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
At least one TEAE324378
At least one SAE17231
PrimaryObjective Response Rate (ORR)

ORR is defined as the percentage of participants whose best overall response (BOR) is the confirmed complete response (CR) or partial response (PR) assessed by investigator using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Time frame:
Up to approximately 4 years and 1 month
Reported as:
Number · Percentage of participants
Objective Response Rate (ORR)
Percentage of participantsSitravatinib MonotherapySitravatinib + Tislelizumab
Anti-PD-1/PD-L1 naïve or R/R HCC25.0 (8.7 to 49.1)—
Anti-PD-1/PD-L1 naïve HCC—11.5 (2.4 to 30.2)
Anti-PD-1/PD-L1 R/R HCC—9.5 (1.2 to 30.4)
Anti-PD-1/PD-L1 naïve G/GEJ cancer—16.1 (5.5 to 33.7)
SecondaryDuration of Response (DOR)

DOR is defined as the time from the first determination of an objective response until the first documentation of progressive disease as assessed by investigator per RECIST v1.1, or death, whichever comes first. Results are reported for indication groups with responders, defined as complete response (CR) or partial response (PR). Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Time frame:
Up to approximately 4 years and 1 month
Reported as:
Median · Months
Duration of Response (DOR)
MonthsSitravatinib MonotherapySitravatinib + Tislelizumab
Anti-PD-1/PD-L1 naïve or R/R HCC7.7 (2.8 to NA)—
Anti-PD-1/PD-L1 naïve HCC—5.7 (4.1 to NA)
Anti-PD-1/PD-L1 R/R HCC—NA (5.4 to NA)
Anti-PD-1/PD-L1 naïve G/GEJ cancer—5.5 (2.7 to NA)
SecondaryDisease Control Rate (DCR)

DCR is defined as the percentage of participants with BOR as CR, PR, or stable disease (SD) assessed by investigator per RECIST v1.1. Efficacy evaluable analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Time frame:
Up to approximately 4 years and 1 month
Reported as:
Number · Percentage of participants
Disease Control Rate (DCR)
Percentage of participantsSitravatinib MonotherapySitravatinib + Tislelizumab
Anti-PD-1/PD-L1 naïve or R/R HCC90.0 (68.3 to 98.8)—
Anti-PD-1/PD-L1 naïve HCC—84.6 (65.1 to 95.6)
Anti-PD-1/PD-L1 R/R HCC—81.0 (58.1 to 94.6)
Anti-PD-1/PD-L1 naïve G/GEJ cancer—71.0 (52.0 to 85.8)
SecondaryProgression-free Survival (PFS)

PFS is defined as the time from the date of first dose to the date of first documentation of progressive disease assessed by the investigator per RECIST v1.1 or death, whichever occurs first. Safety analysis set is presented by indication group, as prespecified in the statistical analysis plan.

Time frame:
Up to approximately 4 years and 1 month
Reported as:
Median · Months
Progression-free Survival (PFS)
MonthsSitravatinib MonotherapySitravatinib + Tislelizumab
Anti-PD-1/PD-L1 naïve or R/R HCC6.8 (4.0 to 7.4)—
Anti-PD-1/PD-L1 naïve HCC—6.8 (2.8 to 8.3)
Anti-PD-1/PD-L1 R/R HCC—4.2 (2.7 to 6.8)
Anti-PD-1/PD-L1 naïve G/GEJ cancer—3.6 (2.8 to 4.7)
SecondaryMaximum Plasma Concentration (Cmax) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on Cycle 1 Day 1 (C1D1) and Cycle 1 Day 21 (C1D21) (21 days in each cycle)
Reported as:
Geometric mean · nanograms/milliliter (ng/mL)
Maximum Plasma Concentration (Cmax) for Sitravatinib
nanograms/milliliter (ng/mL)Sitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
C1D127.11 ± 38.96845.47 ± 67.21337.02 ± 94.99051.07 ± 52.218
C1D2163.98 ± 3.06069.30 ± 78.29856.01 ± 103.43162.38 ± 54.927
SecondaryTime to Maximum Plasma Concentration (Tmax) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Median · Hours (h)
Time to Maximum Plasma Concentration (Tmax) for Sitravatinib
Hours (h)Sitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
C1D110.0 (6.0 to 10.0)7.04 (4.0 to 10.0)10.0 (6.0 to 10.0)7.58 (1.8 to 12.4)
C1D216.00 (6.0 to 12.0)3.04 (2.0 to 4.1)6.00 (0.5 to 10.0)9.15 (0.0 to 12.4)
SecondaryArea Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Geometric mean · h*ng/mL
Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Time Point (AUC(0-t)) for Sitravatinib
h*ng/mLSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
C1D1397.95 ± 25.561761.95 ± 62.680604.63 ± 118.143840.74 ± 59.869
C1D211276.52 ± 3.4981364.56 ± 116.8411095.90 ± 119.3581089.57 ± 91.752
SecondaryClearance After Oral Administration (CL/F) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Geometric mean · Liters/hour
Clearance After Oral Administration (CL/F) for Sitravatinib
Liters/hourSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
C1D192.58 ± NA35.23 ± NA—82.77 ± 62.096
C1D2163.76 ± 5.016—29.14 ± NA78.31 ± 44.296
SecondaryArea Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Geometric mean · h*ng/mL
Area Under the Plasma Concentration-time Curve During the Dosing Interval (AUC(0-tau)) for Sitravatinib
h*ng/mLSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
C1D1535.82 ± NA686.11 ± 122.918—639.49 ± 63.908
C1D211254.71 ± 5.016—2745.23 ± NA1532.33 ± 44.296
SecondaryObserved Accumulation Ratio (Ro) for AUC(0-tau) for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Geometric mean · Ratio
Observed Accumulation Ratio (Ro) for AUC(0-tau) for Sitravatinib
RatioSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
Observed Accumulation Ratio (Ro) for AUC(0-tau) for SitravatinibNA (NA to NA)——3.94 (0.09 to 165.95)
SecondaryObserved Accumulation Ratio (Ro) for Cmax for Sitravatinib
Time frame:
Predose and up to 24 hours postdose on C1D1 and C1D21 (21 days in each cycle)
Reported as:
Geometric mean · Ratio
Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib
RatioSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
Observed Accumulation Ratio (Ro) for Cmax for Sitravatinib2.36 (0.99 to 5.63)2.12 (0.72 to 6.25)1.51 (0.92 to 2.48)1.48 (0.89 to 2.47)
SecondaryPlasma Concentrations of Sitravatinib
Time frame:
Predose and 6 hours postdose in Cycle 5 Day 1 (21 days in each cycle)
Reported as:
Geometric mean · ng/mL
Plasma Concentrations of Sitravatinib
ng/mLSitravatinib MonotherapySitravatinib + Tislelizumab
Predose: Anti-PD-1/PD-L1 naïve or R/R HCC31.64 ± 18.492—
Postdose: Anti-PD-1/PD-L1 naïve or R/R HCC48.12 ± 34.581—
Predose: Anti-PD-1/PD-L1 naïve HCC—23.54 ± 1435.332
Postdose: Anti-PD-1/PD-L1 naïve HCC—77.40 ± 65.582
Predose: Anti-PD-1/PD-L1 R/R HCC—35.95 ± 91.411
Postdose: Anti-PD-1/PD-L1 R/R HCC—54.05 ± 49.017
Predose: Anti-PD-1/PD-L1 naïve G/GEJ cancer—31.13 ± 66.433
Postdose: Anti-PD-1/PD-L1 naïve G/GEJ cancer—42.22 ± 32.131

Adverse events

Collected over From first dose up to 30 days after last dose of study drug(s) or initiation of new anticancer therapy; up to approximately 4 years and 1 month. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Sitravatinib Monotherapy: 80 mg0/3 (0%)1/3 (33.3%)3/3 (100%)
Sitravatinib Monotherapy: 120 mg12/24 (50%)7/24 (29.2%)24/24 (100%)
Sitravatinib 80 mg + Tislelizumab2/3 (66.7%)2/3 (66.7%)3/3 (100%)
Sitravatinib 120 mg + Tislelizumab53/81 (65.4%)31/81 (38.3%)78/81 (96.3%)
Most frequent serious events
Showing 10 of 38
Most frequent serious events
EventSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
IleusGastrointestinal disorders0/30/241/30/81
Intestinal obstructionGastrointestinal disorders0/30/241/30/81
DeathGeneral disorders0/30/241/37/81
PneumoniaInfections and infestations1/30/240/33/81
Venous thrombosis limbVascular disorders0/30/241/30/81
HypersplenismBlood and lymphatic system disorders0/31/240/30/81
Acute coronary syndromeCardiac disorders0/31/240/31/81
Abdominal painGastrointestinal disorders0/31/240/30/81
Hepatic failureHepatobiliary disorders0/31/240/30/81
Myocardial necrosis marker increasedInvestigations0/31/240/30/81
Most frequent other events
Showing 10 of 106
Most frequent other events
EventSitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + Tislelizumab
Alanine aminotransferase increasedInvestigations2/313/243/341/81
Aspartate aminotransferase increasedInvestigations2/313/243/341/81
Weight decreasedInvestigations3/36/241/314/81
HypertensionVascular disorders3/34/242/328/81
Palmar-plantar erythrodysaesthesia syndromeSkin and subcutaneous tissue disorders2/317/240/331/81
HypothyroidismEndocrine disorders2/33/241/316/81
DiarrhoeaGastrointestinal disorders2/314/240/327/81
Platelet count decreasedInvestigations2/310/240/322/81
HypoalbuminaemiaMetabolism and nutrition disorders1/33/242/334/81
HypokalaemiaMetabolism and nutrition disorders2/35/241/39/81

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Sitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + TislelizumabTotal
Mean57.7 ± 10.0253.3 ± 9.9256.3 ± 6.5156.4 ± 10.2355.7 ± 10.1
Sex: Female, Male
Sex: Female, Male(Participants)Sitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + TislelizumabTotal
Female1211014
Male22227197
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Sitravatinib Monotherapy: 80 mgSitravatinib Monotherapy: 120 mgSitravatinib 80 mg + TislelizumabSitravatinib 120 mg + TislelizumabTotal
Asian: Chinese324381111
08

Study locations

18 sites
  • The Second Hospital of Anhui Medical University
    Hefei, Anhui 230601, China
  • Beijing Cancer Hospital
    Beijing, Beijing 100142, China
  • Fujian Medical University Union Hospital
    Fuzhou, Fujian 350001, China
  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)
    Guangzhou, Guangdong 510000, China
  • Nanfang Hospital of Southern Medical University
    Guangzhou, Guangdong 510515, China
  • Harbin Medical University Cancer Hospital
    Harbin, Heilongjiang 150000, China
  • Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
    Wuhan, Hubei 430022, China
  • Zhongnan Hospital of Wuhan University Wuhan
    Wuhan, Hubei 430071, China
  • Hubei Cancer Hospital
    Wuhan, Hubei 430079, China
  • General Hospital of Eastern Theatre Command Qihuaiyuan Branch(the St Hospital of Chinese Pla)
    Nanjing, Jiangsu 210002, China
  • The First Affiliated Hospital of Nanchang University Branch Donghu
    Nanchang, Jiangxi 330006, China
  • Liaoning Cancer Hospital and Institute
    Shenyang, Liaoning 110042, China
  • Fudan University Shanghai Cancer Center
    Shanghai, Shanghai 200000, China
  • Affiliated Zhongshan Hospital of Fudan University
    Shanghai, Shanghai 200032, China
  • Shanghai East Hospital Branch Hospital
    Shanghai, Shanghai 200123, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310003, China
  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
    Hangzhou, Zhejiang 310016, China
  • Zhejiang Cancer Hospital
    Hangzhou, Zhejiang 310022, China
09

References and documents

Publications

  • Zhang, F., et al. Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic hepatocellular carcinoma (HCC). Journal of Clinical Oncology 2022 40:4_suppl, 418; Meeting Abstract, 2022 ASCO Gastrointestinal Cancers Symposium; https://doi.org/10.1200/JCO.2022.40.4_suppl.418
  • Chen Z., et al. Safety, tolerability, and preliminary antitumor activity of sitravatinib plus tislelizumab (TIS) in patients (pts) with unresectable locally advanced or metastatic gastric cancer/gastroesophageal junction cancer (GC/GEJC). Journal of Clinical Oncology 2022 40:4_suppl, 281-281; Meeting Abstract, ASCO Gastrointestinal Cancers Symposium, Abstract 281.

Study documents

  • Study protocol · Apr 28, 2020
  • Statistical analysis plan · Apr 10, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03941873
Lead sponsor
BeiGene
Responsible party
Sponsor
First posted
May 8, 2019
Start date
Feb 28, 2019
Primary completion
Mar 31, 2023
Completion
Mar 31, 2023
Results posted
Oct 18, 2024
Last update
Oct 26, 2024

Study contacts

Study Director
study director · BeiGene

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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