CompletedNCT01512745Updated Oct 17, 2016Results posted

Phase III Study of Apatinib Tablets in the Treatment of Advanced or Metastatic Gastric Cancer

A Phase 3 interventional study of apatinib and placebo in Advanced or Metastatic Gastric Cancer, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-10-17.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 267
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The investigators' phase I study has shown that the drug's toxicity is manageable and the maximum tolerable daily dose is 850 mg. The purpose of this study is to determine whether apatinib can improve progression free survival or overall survival compared with placebo in patients with metastatic gastric carcinoma who failed two lines of chemotherapy.

Conditions studied

Advanced or Metastatic Gastric Cancer

Browse trials for

Stomach Neoplasms 2,851

In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's enrollment of 267 is above the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.

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Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 559 studies on the registry; 85 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 1 (11%) have results posted.

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

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

≥ 18 and ≤ 70 years of age
Histological confirmed advanced or metastatic adenocarcinoma of the stomach
Have failed for at least 2 lines of chemotherapy
Life expectancy of at least 12 weeks.
Eastern Cooperative Oncology Group Performance Status of 0 or 1 within 1 week before randomization.
At least one measurable lesion beyond stomach (larger than 10 mm in diameter by spiral CT scan)
Duration from the last therapy is more than 6 weeks for nitroso or mitomycin
More than 4 weeks for operation or radiotherapy
More than 4 weeks for cytotoxic agents or growth inhibitors
Adequate hepatic, renal, heart, and hematologic functions (HB ≥ 90g/L,platelets > 80 ×10 E+9/L, neutrophil > 1.5 × 10 E+9/L, serum creatinine ≤ 1× upper limit of normal(ULN), bilirubin \< 1.25× ULN, and serum transaminase ≤ 2.5× ULN).

Exclusion criteria

Exclusion Criteria:

Pregnant or lactating women
History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Hypertension and unable to be controlled within normal level following treatment of anti-hypertension agents (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg).
Any factors that influence the usage of oral administration; Evidence of Central Nerves System(CNS) metastasis
Intercurrence with one of the following: coronary artery disease, arrhythmia ,heart failure and proteinuria ≥ (+)
International Normalize Ratio (INR) > 1.5 and activated partial thromboplastin time（APPT） > 1.5 × ULN
Abuse of alcohol or drugs
Certain possibility of gastric or intestine hemorrhage
Less than 4 weeks from the last clinical trial
Prior VEGFR inhibitor treatment
Disability of serious uncontrolled intercurrence infection Objective evidence of previous or current pulmonary fibrosis history, interstitial pneumonia, Pneumoconiosis, radiation pneumonitis, drug-related pneumonia, Pulmonary function damaged seriously etc.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 267 participants (actual)

Study arms

Experimental
apatinib
Drug: apatinib
Placebo comparator
placebo
Drug: placebo

Interventions

Drugapatinib
apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
Drugplacebo
placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent

What researchers measure

Primary outcomes

Progression Free Survival(PFS)
Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Time frame: 30 months
Overall Survival(OS)
Overall Survival of the Participants
Time frame: 30 months

Secondary outcomes

Disease Control Rate(DCR)
Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.
Time frame: 30 months
Objective Response Rate(ORR)
Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)
Time frame: 30 months
Percentage of Participants With Adverse Events
Time frame: 30 months

Results

Posted Jun 15, 2016

Participant flow

Participant flow — Overall Study
Milestone	Apatinib	Placebo
Started	176	91
Completed	136	71
Not completed	40	20
Withdrew: Adverse event	22	3
Withdrew: Death	9	13
Withdrew: Withdrawal by subject	2	2
Withdrew: Lost to follow-up	4	0
Withdrew: Lack of efficacy	2	2
Withdrew: Protocol violation	1	0

Outcome measures

PrimaryProgression Free Survival(PFS)

Progression free survival of All the Evaluable Participants.Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as at least a 20% increase in the sum of diameters of target lesions, in addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).

Time frame:: 30 months
Reported as:: Median · month

Progression Free Survival(PFS)
month	Apatinib	Placebo
Progression Free Survival(PFS)	2.6 (2.0 to 2.9)	1.8 (1.4 to 1.9)

PrimaryOverall Survival(OS)

Overall Survival of the Participants

Time frame:: 30 months
Reported as:: Median · month

Overall Survival(OS)
month	Apatinib	Placebo
Overall Survival(OS)	6.5 (4.8 to 7.6)	4.7 (3.6 to 5.4)

SecondaryDisease Control Rate(DCR)

Disease control is defined as the proportion of patients who had a best response rating of complete response, partial response, or stable disease, and lasted at least 4 weeks.

Time frame:: 30 months
Reported as:: Number · percentage of participants

Disease Control Rate(DCR)
percentage of participants	Apatinib	Placebo
Disease Control Rate(DCR)	42.05	8.79

SecondaryObjective Response Rate(ORR)

Objective Response Rate is defined as the proportion of patients with complete response(CR) or partial response(PR)

Time frame:: 30 months
Reported as:: Number · percentage of participants

Objective Response Rate(ORR)
percentage of participants	Apatinib	Placebo
Objective Response Rate(ORR)	2.84	0.00

SecondaryPercentage of Participants With Adverse Events

Time frame:: 30 months
Reported as:: Number · percentage of participants

Percentage of Participants With Adverse Events
percentage of participants	Apatinib	Placebo
Percentage of Participants With Adverse Events	98.30	90.11

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Apatinib	—	6/176 (3.4%)	173/176 (98.3%)
Placebo	—	6/91 (6.6%)	82/91 (90.1%)

Most frequent serious events

Most frequent serious events
Event	Apatinib	Placebo
Gastrointestinal bleedingGastrointestinal disorders	5/176	5/91
Abdominal painGastrointestinal disorders	1/176	1/91

Most frequent other events

Showing 10 of 18

Most frequent other events
Event	Apatinib	Placebo
proteinuriaRenal and urinary disorders	84/176	15/91
leukopeniaBlood and lymphatic system disorders	71/176	8/91
neutropeniaBlood and lymphatic system disorders	66/176	9/91
hypertensionVascular disorders	62/176	5/91
hand-foot syndromeSkin and subcutaneous tissue disorders	49/176	2/91
elevated transaminaseHepatobiliary disorders	49/176	20/91
anemiaBlood and lymphatic system disorders	44/176	22/91
thrombocytopeniaBlood and lymphatic system disorders	44/176	6/91
hyperbilirubinemiaHepatobiliary disorders	43/176	13/91
bleedingBlood and lymphatic system disorders	35/176	22/91

Baseline characteristics

5 participants in the apatinib group and 1 in the placebo group withdrew from the study before receiving the assigned treatments.As a result,267 randomly assigned participants were included in Full Analysis Set （FAS），with 176 assigned to the apatinib group and 91 assigned to the placeo group.

Age, Continuous
Age, Continuous(years)	Apatinib	Placebo	Total
Mean	55.01 ± 9.92	56.08 ± 9.74	55.37 ± 9.81

Sex: Female, Male
Sex: Female, Male(Participants)	Apatinib	Placebo	Total
Female	44	22	66
Male	132	69	201

Study locations

2 sites

The 81 Hosiptal of PLA
Nanjing, Jiangsu, China
Fudan University cancer hospital
Shanghai, Shanghai, China

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 17, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01512745
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Collaborators: Fudan University, The 81 Hospital of PLA
Responsible party: Sponsor
First posted: Jan 19, 2012
Start date: Jan 2011
Primary completion: May 2013
Completion: May 2013
Results posted: Jun 15, 2016
Last update: Oct 17, 2016

Study contacts

Jin Li, MD, PHD

principal investigator · Fudan University

Shukui Qin, MD

principal investigator · The 81 Hospital of PLA

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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