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

NCT04139135 | Unknown Phase 3

• 1 other identifier: HLX10-006-GCneo
• Study Type: interventional
• Target: 642
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• EFS

  from randomizationuntil firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 3 years

• DFS

  from the start of surgery to disease recurrence or death (for any reason)，assessed up to 3 years

• pCR rate

  after surgery，an average of 6 months

• 5-year OS rate

  OS is the time from randomization to death (of any cause)，assessed up to 5 years

Study Arms (2)

HLX10

EXPERIMENTAL

HLX10 combined with chemotherapy will be adopted in the neoadjuvant treatment phase, and HLX10 monotherapy will be administered in the adjuvant treatment phase

Drug: HLX10

Placebo

PLACEBO COMPARATOR

Placebo combined with chemotherapy will be given in the neoadjuvant treatment phase, and chemotherapy alone will be administered during the adjuvant treatment phase.

Drug: Placebos

Interventions

HLX10 DRUG

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

Also known as: Recombinant humanized anti-PD-1 monoclonal antibody injection

HLX10

Placebos DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• The gender is not limited. When ICF is signed, the age is ≥ 18 years and ≤ 70 years old.
• Histologically confirmed untreated gastric cancers, mainly adenocarcinoma.
• 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.
• Prior to enrollment, the attending physician will evaluate to determine the eligibility for a R0 resection for the purpose of radical treatment.
• Have good cardiac function and can be treated with radical resection.
• 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.
• Within 7 days before the first use of the study drug, ECOG: 0 \~ 1;
• Expected survival 12 weeks;
• The functions of the vital organs meet requirements.

You may not qualify if:

• Existence of other active malignant tumors within 5 years or at the same time.
• Plan to perform or have undergone an organ or bone marrow transplant.
• Myocardial infarction and poorly controlled arrhythmias occurred within 6 months prior to the first dose.
• Existence of grade III - IV cardiac disorders defined by the NYHA or echocardiogram shows: LVEF (left ventricular ejection fraction) \< 50%.
• Human immunodeficiency virus (HIV) infection.
• Patients with active tuberculosis.
• Patient with previous or current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-associated pneumonia, severely impaired lung function, etc.
• Patients who have previously received other antibody/drug treatments for immune checkpoints, such as PD-1, PD-L1, and CTLA4 treatments.
• 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.

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (15)

Peking University shenzhen hospital

Shenzhen, Guangdong, China

RECRUITING

Affiliated Hospital of Hebei University

Baoding, China

RECRUITING

Beijing Cancer Hospital

Beijing, China

RECRUITING

China PLA General Hospital

Beijing, China

RECRUITING

Peking University International Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

The First Affiliated Hospital of Bengbu Medical College

Bengbu, China

RECRUITING

Cangzhou People's Hospital

Cangzhou, China

RECRUITING

Anhui Provincial Hospital

Hefei, China

RECRUITING

The First Affiliated Hospital of Anhui Medical University

Hefei, China

RECRUITING

Linyi Cancer Hospital

Linyi, China

RECRUITING

The Fourth Hospital of Hebei Medical University

Shijia Zhuang, China

RECRUITING

Shanxi Provincial People's Hospital

Taiyuan, China

RECRUITING

Tianjin Medical University Institute & Hospital

Tianjin, China

RECRUITING

Xingtai People's Hospital

Xingtai, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Central Study Contacts

Jiafu JI

CONTACT

010-88140650; jijiafu@hsc.pku.edu.cn

Lin Shen

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2019
• First Posted: October 25, 2019
• Study Start: December 12, 2019
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2024
• Last Updated: June 6, 2022

Record last verified: 2022-06

Locations

CN (15)