A Clinical Study of HLX10 Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Randomized, Double-blinded, Multicenter, Phase III Clinical Study of HLX10 (Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection) Combined With Chemotherapy Versus Placebo Combined With Chemotherapy for Neoadjuvant/Adjuvant Treatment of Gastric Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04139135
• Other study ID #: HLX10-006-GCneo
• Status: Recruiting
• Phase: Phase 3
• Start date: December 12, 2019
• Est. completion date: October 2024

Study information

• Verified date: June 2022
• Source: Shanghai Henlius Biotech
• Contact: Jiafu JI
• Phone: 010-88140650
• Email: jijiafu[@]hsc.pku.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a two-arm, randomized, double-blinded, multicenter phase III clinical study to evaluate the efficacy of HLX10 combined with chemotherapy versus placebo combined with chemotherapy for neoadjuvant/adjuvant treatment of gastric cancer.

Subjects will be randomized to the following two arms at 1: 1 ratio:

• Arm A (HLX10 arm): HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase;

• Arm B (control arm): Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.

Chemotherapy regimen SOX (oxaliplatin + tegafor gimeracil oteracil potassium (S-1)) will be used in the neoadjuvant treatment phase in Arm A and B, and in the adjuvant treatment phase in Arm B.

After randomization, subjects will receive a total of 3 cycles of neoadjuvant treatment with the mentioned treatment regimen.Surgery will be performed within 3-6 weeks after the last cycle of neoadjuvant treatment.All subjects who have completed the surgery will be unblinded after surgery, and adjuvant treatment will be started 3 to 12 weeks after surgery. Subjects randomized to Arm A (HLX10 arm) will continue to receive HLX10 monotherapy for up to 17 cycles (12 months).Subjects in Arm B after surgery (control arm) will continue to use chemotherapy alone (oxaliplatin + S-1) for 5 cycles.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 642
• Est. completion date: October 2024
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.

2. The gender is not limited. When ICF is signed, the age is = 18 years and = 70 years old.

3. Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.

4. Within 4 weeks prior to first dose, determined by the Independent Radiology Review Committee (IRRC) as: = T3 and number of lymph node metastases = 1 and no distant metastasis.

5. Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.

6. Have good cardiac function and can be treated with radical resection.

7. tumor specimen testing results are PD-L1 positive (CPS =5). Subjects must provide the tumor tissues at screening or in the investigated surgery (if any), for PD-L1 expression level assessment.

8. Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;

9. Expected survival 12 weeks;

10. The functions of the vital organs meet requirements.

Exclusion Criteria:

1. Existence of other active malignant tumors within 5 years or at the same time.

2. Plan to perform or have undergone an organ or bone marrow transplant.

3. Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.

4. Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) < 50%.

5. Human immunodeficiency virus (HIV) infection.

6. Patients with active tuberculosis.

7. Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.

8. Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.

9. Have diseases that may increase the risk of participating in the study and using the study medications, or other severe, acute, and chronic diseases and therefore are judged by the investigator to be unsuitable for clinical studies.

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• HLX10
neoadjuvant treatment phase:HLX10(4.5mg/kg/3w IV) +SOX, adjuvant treatment phase:HLX10(4.5mg/kg/3w IV)
• Placebos
neoadjuvant treatment phase:placebos(4.5mg/kg/3w IV) +SOX, adjuvant treatment phase:SOX

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding
China	Beijing Cancer Hospital	Beijing
China	China PLA General Hospital	Beijing
China	Peking University International Hospital	Beijing
China	Peking University Third Hospital	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu
China	Cangzhou People's Hospital	Cangzhou
China	Anhui Provincial Hospital	Hefei
China	The First Affiliated Hospital of Anhui Medical University	Hefei
China	Linyi Cancer Hospital	Linyi
China	Peking University shenzhen hospital	Shenzhen	Guangdong
China	The Fourth Hospital of Hebei Medical University	Shijia Zhuang
China	Shanxi Provincial People's Hospital	Taiyuan
China	Tianjin Medical University Institute & Hospital	Tianjin
China	Xingtai People's Hospital	Xingtai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Henlius Biotech

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFS	event-free survival (assessed by independent radiological review committee (IRRC) based on RECIST v1.1)	from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
Secondary	EFS	Event-free survival (assessed by the investigator per RECIST v1.1 criteria)	from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 3 years
Secondary	DFS	Disease-free survival (assessed by the investigator per RECIST v1.1 criteria)	from the start of surgery to disease recurrence or death (for any reason),assessed up to 3 years
Secondary	pCR rate	Pathological complete response (pCR) rate (assessed by central pathology laboratory and the site)	after surgery,an average of 6 months
Secondary	5-year OS rate	5-year overall survival (OS) rate	OS is the time from randomization to death (of any cause),assessed up to 5 years