ESCC or Esophageal Adenosquamous CarcinomaPhase 2NCT05221658
A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy or Monotherapy in Patients With Advanced ESCC
A Phase 2 study testing HLX07+HLX10+ Cisplatin+5-FU and HLX07 in people with ESCC or Esophageal Adenosquamous Carcinoma, run by Shanghai Henlius Biotech at 17 sites in China.
Trial summary
This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ESCC or Esophageal Adenosquamous Carcinoma
- What is being tested?
- HLX07+HLX10+ Cisplatin+5-FU and HLX07
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 17 sitesChina
- Study dates
- 25 Aug 2022to 30 Aug 2025
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who meet all of the following criteria are allowed to be enrolled into this study:
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF); be willing to follow and be able to complete all study procedures;
- Age ≥ 18 years and ≤ 75 years when ICF is signed;
- Histopathologically or cytologically confirmed diagnosis of locally advanced, unresectable or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma.
- Subjects in Arm B1 and Arm B2 must provide eligible tumor tissue for EGFR expression level determination： Arm B1: Subjects with EGFR expression H score ≥ 200 confirmed by central laboratory immunohistochemistry (IHC) in tumor tissue.
- Arm B2: Subjects with EGFR expression H score < 200 confirmed by central laboratory IHC.
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- prior therapy: Arm A: Never received systemic anti-tumor drug therapy before. Exception: for patients who have received neoadjuvant/adjuvant treatment, the time from the last treatment to recurrence or progression can be screened for more than 6 months; Arms B1 and B2: Failed or intolerant to prior systemic anti-tumor therapy (at least 2 lines).
- According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the investigator with at least one measurable lesions (such as esophageal cavity structure not as measurable lesions), measurable lesions should be not received radiotherapy, etc (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion);
- 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 the following requirements (no blood transfusion, cytokine growth factor, or platelet raising drugs are allowed within 14 days before the first use of the study drugs); Absolute neutrophil count (ANC) ≥1.5×109/L platelet≥ 100×109/L; Hemoglobin≥ 90g/L; Serum albumin≥ 30g/L; Total bilirubin≤ 1.5 ULN, ALT, AST and/or ALP≤ 2.5 ULN;ALT and/or AST≤ 5 ULN in the presence of liver metastasis;If there is liver metastasis or bone metastasis ALP≤ 5 ULN; Serum creatinine ≤1.5 ULN or creatinine clearance > 50 mL/min (Cockcroft-Gault formula); APTT, INR and PT ≤1.5 ULN;
- For fertile female subjects, the serum pregnancy test must be negative within 7 days before the first dose.
- With fertile women subjects, and the partner for childbearing age women of male subjects, needs during the therapy, and after the last use HLX10 / placebo at least 6 months and the last time to use at least 6 months after chemotherapy using an approved by the medical contraception (such as intrauterine device, the pill or condoms)
Who cannot join
- Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
- A history of gastrointestinal perforation and/or fistula within 6 months prior to the first administration;
- Obvious invasion of tumor into adjacent organs (aorta or trachea) of esophageal lesions leads to high risk of bleeding or fistula;3. Subjects after endotracheal stent implantation;
- Uncontrollable pleural effusion, pericardial effusion or ascites requiring repeated drainage;
- Previous allergies to monoclonal antibody, HLX10, 5-fu, cisplatin and other platinum drugs;
- Have received any of the following treatments:
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- A.Prior systemic anti-EGFR monoclonal antibody therapy Previous treatment with anti-pd-1 or anti-pd-L1 antibodies （Arm A）; B. Have received any research drugs within 4 weeks before the first use of the study drugs; C. Be enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or a follow-up interventional clinical study; D. Receive the final anticancer treatment within 4 weeks before the first use of the study drug;Palliative radiotherapy for bone metastases was allowed and was completed 2 weeks before the first dose.Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days before the first dose.
- Subjects who require systemic treatment with corticosteroids (> 10 mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to the first use of the study drug;In the absence of active autoimmune disease, inhalation or topical use of steroids is permitted, and the therapeutic dose of prednisone 10mg/ day is allowed.
- Those who have received the anti-tumor vaccine or the live vaccine within 4 weeks before the first dose of the study drug; G. Have undergone major surgery within 28 days prior to the first use of the study drug. Major surgery in this study is defined as requiring at least 3 weeks of postoperative recovery time before being able to receive the surgery treated in this study.Tumor puncture or lymph node biopsy were allowed.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
China17 sites, 17 recruiting
- Not yet recruiting
Anyang Cancer Hospital
Anyang, Hebei
Tao Wu, wuren909@163.com
- Recruiting
Cancer Hospital Chinese Academic of Medical Sciences
Beijing, Beijing Municipality
Jing Huang, huangjingwg@163.com
- Not yet recruiting
Hunan Cancer Hospitla
Changsha, Hunan
Zhenyang Liu, liuzhenyang@hnca.org.cn
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Jin Zhou, zhoujt521@163.com
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian
Wu Zhuang, zhuangwu2008@126.com
- Not yet recruiting
Shandong Cancer Hospital
Jinan, Shandong
Bo Liu, Lb20201110@163.com
- Not yet recruiting
Affiliated Hospital of Jining Medical University
Jining, Shandong
Junye Wang, jiningwangjunye@163.com
- Not yet recruiting
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan
qing Bi, jiningwangjunye@163.com
- Not yet recruiting
Jiangsu Cancer Hospital & Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital
Nanjing, Jiangsu
Guochun Cao, caoguochun@csco.ac.cn
- Not yet recruiting
Jiangsu People Hospital & The First Affiliated with Nanjing Medical University
Nanjing, Jiangsu
Lianke Liu, liulianke@jsph.org.cn
- Not yet recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality
Jiayan Chen, chenjiayan2008@126.com
- Not yet recruiting
Cancer Hospital Chinese Academic of Medical Sciences, Shenzhen Center
Shenzhen, Guangdong
Ying wang, 949898789@qq.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Mudan Yang, yangmd6000@163.com
- Not yet recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Feng Ye, zhoujt521@163.com
- Not yet recruiting
Xingtai People's Hospital
Xingtai, Hebei
Zhenbo Tan, tanzhbo@126.com
- Not yet recruiting
Xuzhou Center Hospital
Xuzhou, Jiangsu
Yuan Yuan, wwww8866@163.com
- Not yet recruiting
Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University
Zhenzhou, Henan
Ning Li, happy201901@126.com
About this study
Official title: An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score < 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
- Being tested
- HLX07+HLX10+ Cisplatin+5-FU, HLX07
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX07+HLX10+ Cisplatin+5-FUDrug
HLX07 1000mg + HLX10 200mg + Cisplatin 50 mg/m2 + 5-FU 2400mg/m2
HLX07Drug
HLX07 1000mg iv Q2w
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | As first-line therapy Receives: Drug: HLX07+HLX10+ Cisplatin+5-FU |
| Arm B1 | Experimental | EGFR H score ≥ 200, as third-line or above therapy Receives: Drug: HLX07 |
| Arm B2 | Experimental | EGFR H score <200, as third-line or above therapy Receives: Drug: HLX07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate by IRRC/INV assessment per RECIST
Measured: up to 2 years
PFS
Progression-free survival by IRRC/INV assessment per RECIST
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Secondary outcomes (2)
OS
Ooverall survival
Measured: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
DOR
Duration of response
Measured: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start25 Aug 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ESCC or Esophageal Adenosquamous CarcinomaStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221658
- Sponsor's protocol ID
- HLX07-ESCC201
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2022
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu Y, Wang Y, Zhu Y, Wu T, Liu Z, Zhou J, Yuan Y, Yang M, Liu B, Tan Z, Zhuang W, Chen J, Li N, Wang Y, Hu X, Wang L, Yu H, Wang Q, Zhu J, Huang J. HLX07 alone or combined with serplulimab, cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study. Cancer Commun (Lond). 2024 Dec;44(12):1431-1443. doi: 10.1002/cac2.12621. Epub 2024 Oct 24.
PubMed 39446605
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter , Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07 ( Recombinant Humanized Anti-EGFR Monoclonal Antibody Injection) Combination Therapy or Monotherapy in Patients With Locally Advanced, Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
- ClinicalTrials.gov ID
- NCT05221658
- Acronym / sponsor ID
- HLX07-ESCC201
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is conducted in patients with Locally advanced, unresectable, or metastatic esophageal squamous cell carcinoma (ESCC) or esophageal adenosquamous carcinoma. This study includes three arms: A, B1, and B2. Arm A will receive HLX07 combination therapy with HLX10 and Chemotherapy (Cisplatin+5-FU) as first line treatment. Arm B (Patients with EGFR expression H score ≥ 200) and Arm C (Patients with EGFR expression H score < 200) will receive HLX07 monotherapy as third-line or above treatment. All of eligible patients will receive study drug treatment until loss of clinical benefit, unacceptable toxicity, death, withdrawal of informed consent (whichever occurs first, HLX10 treatment up to 2 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: HLX07+HLX10+ Cisplatin+5-FUAs first-line therapy |
| Arm B1 | Experimental | Drug: HLX07EGFR H score ≥ 200, as third-line or above therapy |
| Arm B2 | Experimental | Drug: HLX07EGFR H score <200, as third-line or above therapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects who meet all of the following criteria are allowed to be enrolled into this study:
- Arm B2: Subjects with EGFR expression H score < 200 confirmed by central laboratory IHC.
- prior therapy: Arm A: Never received systemic anti-tumor drug therapy before. Exception: for patients who have received neoadjuvant/adjuvant treatment, the time from the last treatment to recurrence or progression can be screened for more than 6 months; Arms B1 and B2: Failed or intolerant to prior systemic anti-tumor therapy (at least 2 lines).
- According to the curative effect evaluation criteria in solid tumors (RECIST) v1.1, assessed by the investigator with at least one measurable lesions (such as esophageal cavity structure not as measurable lesions), measurable lesions should be not received radiotherapy, etc (lesions located in the usual radiation area, if confirm progress, can also be selected as the target lesion);
- Within 7 days before the first use of the study drug, ECOG: 0 ~ 1;
Key exclusion criteria (9 listed)
- Subjects who meet any of the following criteria are not allowed to be enrolled in this study:
- A.Prior systemic anti-EGFR monoclonal antibody therapy Previous treatment with anti-pd-1 or anti-pd-L1 antibodies （Arm A）; B. Have received any research drugs within 4 weeks before the first use of the study drugs; C. Be enrolled in another clinical study at the same time, unless it is an observational (non-interventional) clinical study or a follow-up interventional clinical study; D. Receive the final anticancer treatment within 4 weeks before the first use of the study drug;Palliative radiotherapy for bone metastases was allowed and was completed 2 weeks before the first dose.Radiotherapy covering more than 30% of the bone marrow area is not allowed within 28 days before the first dose.
- Subjects who require systemic treatment with corticosteroids (> 10 mg/ day prednisone therapeutic dose) or other immunosuppressive agents within 14 days prior to the first use of the study drug;In the absence of active autoimmune disease, inhalation or topical use of steroids is permitted, and the therapeutic dose of prednisone 10mg/ day is allowed.
- Those who have received the anti-tumor vaccine or the live vaccine within 4 weeks before the first dose of the study drug; G. Have undergone major surgery within 28 days prior to the first use of the study drug. Major surgery in this study is defined as requiring at least 3 weeks of postoperative recovery time before being able to receive the surgery treated in this study.Tumor puncture or lymph node biopsy were allowed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HLX07+HLX10+ Cisplatin+5-FUHLX07 1000mg + HLX10 200mg + Cisplatin 50 mg/m2 + 5-FU 2400mg/m2 | Drug | Arm A |
| HLX07HLX07 1000mg iv Q2w | Drug | Arm B1, Arm B2 |
Primary outcome
ORR
Time frame: up to 2 years
Objective response rate by IRRC/INV assessment per RECIST
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier),assessed up to 2 years
Progression-free survival by IRRC/INV assessment per RECIST
2 secondary outcomes
OS
Time frame: from the date of first dose unitl the date of death from any cause，assessed up to 2 years
DOR
Time frame: from the date when CR or PR (whichever recorded earlier) is firstly achieved until the date when disease progression or death is firstly recorded (whichever occurs earlier),assessed up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
- Derived from this study: PubMed 39446605Liu Y, Wang Y, Zhu Y, Wu T, Liu Z, Zhou J, Yuan Y, Yang M, Liu B, Tan Z, Zhuang W, Chen J, Li N, Wang Y, Hu X, Wang L, Yu H, Wang Q, Zhu J, Huang J. HLX07 alone or combined with serplulimab, cisplatin and 5-fluorouracil for advanced esophageal squamous cell carcinoma: A phase 2 study. Cancer Commun (Lond). 2024 Dec;44(12):1431-1443. doi: 10.1002/cac2.12621. Epub 2024 Oct 24.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HLX07+HLX10+ Cisplatin+5-FU and HLX07 in people with ESCC or Esophageal Adenosquamous Carcinoma, run by Shanghai Henlius Biotech at 17 sites 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 13 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 29 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Huang ((010)87788102, huangjingwg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 2 years). The study lists 2 primary outcomes in all. 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 NCT05221658, which also lists 1 linked publication.
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 29 Aug 2022.