CarcinomaPhase 2EXPLORINGNCT05494060
XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma
A Phase 2 study testing Anlotinib hydrochloride capsule, Penpulimab Injection and XELOX in people with Carcinoma and Gastrointestinal Diseases, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Carcinoma, Gastrointestinal Diseases, Stomach Cancer
- What is being tested?
- Anlotinib hydrochloride capsule, Penpulimab Injection and XELOX
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 16 Mar 2022to Feb 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 aged ≥18 and ≤75 years old, male or female.
- ECOG performance status score 0-1.
- Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.
- Pathological stage:III (8th AJCC TNM).
- Estimated lifetime is greater than 6 months.
- The main organs are functioning well, and the blood test results within 14 days before enrollment should meet the following requirements:
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- Routine blood test:
- Hemoglobin (HB) ≥90 g/L.
- Neutrophil count (ANC) ≥1.5×109/L.
- Platelet count (PLT) ≥100×109/L.
- Biochemical test:
- Total bilirubin≤1.5×ULN (upper limit of normal).
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; if there is liver metastasis, ALT and AST ≤ 5×ULN.
- Serum creatinine (Cr) ≤1.5 ULN or creatinine clearance ≥60mL/min.
- No obvious clinical symptoms of heart disease.
- Must have disease-free status documented by complete physical examination and imaging studies with no evidence of recurrent, residual, or metastatic disease on standard imaging (chest, abdomen, and pelvis captured by CT chest and CT or MRI of abdomen and pelvis) per investigator assessment within 28 days prior to enrollment.
- Females of childbearing potential must have a negative urine or serum pregnancy test within 7 days of randomization and must be willing to use a highly effective method of birth control (Appendix 9) for the duration of the study, and ≥ 120 days after the last dose of penpulimab and 180 days after the last dose of chemotherapy.
- Volunteer to participate in this study and sign an informed consent form.
- Considering that NGS analysis may take up to 10 working days, patients could receive 1 cycle of XELOX chemotherapy after ctDNA sampling.
Who cannot join
- Participation in other drug clinical trials within four weeks.
- Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
- History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.
- Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.
- Long-term unhealed wound or unhealed fracture.
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- Imaging findings show that the tumor has invaded around important blood vessels or the patient's tumor has a very high possibility of invading important blood vessels during treatment and causing fatal massive hemorrhage as judged by the investigator.
- Patients with abnormal coagulation function and bleeding tendency (the following criteria must be met within 14 days before randomization: INR is within normal range without anticoagulants or has no clinically significant abnormality); patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or their analogues; patients with prothrombin time international normalized ratio (INR) ≤ 1.5 are allowed to take low-dose warfarin (1 mg orally, once daily) or low-dose aspirin (the daily dose does not exceed 100 mg) for preventive purposes.
- Arteriovenous thrombotic events occurred within 6 months before screening, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis (except venous thrombosis caused by previous chemotherapy that has been judged by the investigator to have recovered) and pulmonary embolism.
- Urine routine showed urine protein and 24 h urine protein was confirmed to be > 1.0g.
- Previous use of immune targeted therapy drugs.
- History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
- Patients with infectious pneumonia, pneumonitis, interstitial pneumonia and other conditions requiring corticosteroids.
- History of severe chronic autoimmune diseases, such as systemic lupus erythematosus; history of inflammatory bowel disease such as ulcerative enteritis, Crohn's disease, irritable bowel syndrome and other chronic diarrheal diseases; history of sarcoidosis or tuberculosis; history of active hepatitis B, C and HIV infection; well-controlled non-serious immune diseases, such as dermatitis, arthritis, psoriasis, etc. Hepatitis B virus < 1000 copies/ml can be detected.
- Patients with hypersensitivity to human or murine monoclonal antibodies.
- Patients with a history of psychotropic substance abuse and unable to quit or with mental disorders.
- Pleural or peritoneal effusion with clinical symptoms requiring clinical intervention.
- Patients who do not follow the doctor's advice, do not take medicine as required, or have insufficient data that can affect the efficacy judgment or safety judgment.
- Patients with concomitant diseases that, in the judgment of the investigator, seriously jeopardize the patient's safety or affect the patient's completion of the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Yongqian Shu, PhD, 00862568306428, shuyongqian@csco.org.cn
Xiaofeng Chen, PhD, 008613585172006, xiaofengch198019@126.com
About this study
Official title: XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.
Read the detailed description
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma. The study includes a screening (up to 28 days), treatment (disease recurrence, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month), safety follow-up (up to 30 days following last study drug treatment), and survival follow-up phase.
- Conditions
- Carcinoma, Gastrointestinal Diseases, Stomach Cancer, Gastroesophageal-junction Cancer, Digestive System Diseases, Gastric Cancer
- Being tested
- Anlotinib hydrochloride capsule, Penpulimab Injection, XELOX
- Keywords
- Penpulimab, Anlotinib, Capecitabine, Oxaliplatin, ctDNA, adjuvant therapy
- Medical subject headings
- Carcinoma, Gastrointestinal Diseases, Stomach Neoplasms, Digestive System Diseases, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib hydrochloride capsuleDrug
Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
Penpulimab InjectionDrug
Also called AK-105
Penpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days
XELOXDrug
Also called Capecitabine and Oxaliplatin
Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w
| Study group | Role | What they receive |
|---|---|---|
| Penpulimab + Anlotinib + XELOX | Experimental | Penpulimab in combination with Anlotinib and XELOX (Capecitabine and Oxaliplatin) Receives: Drug: Anlotinib hydrochloride capsule; Drug: Penpulimab Injection; Drug: XELOX |
| XELOX | Active comparator | XELOX (Capecitabine and Oxaliplatin) Receives: Drug: XELOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Free Survival (DFS)
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence).
Measured: up to 2 years
Secondary outcomes (2)
Disease Free Survival (DFS) rate at 2 years
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), assessed at 2 years.
Measured: 2 years
Disease Free Survival (DFS) rate at 3 years
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence), assessed at 3 years.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start16 Mar 2022
- Primary completionDec 2024 (estimated)
- Study completionFeb 2027 (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 CarcinomaStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Penpulimab + Anlotinib + XELOX； Active Comparator: XELOX
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Ext: Shu, PhD, Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494060
- Sponsor's protocol ID
- 2022-SR-342
- Acronym
- EXPLORING
- Status last verified
- Nov 2023
- First submitted
- 8 Aug 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Chen Y, Zhang J, Han G, Tang J, Guo F, Li W, Xie L, Xu H, Zhang X, Tian Y, Pan L, Shu Y, Ma L, Chen X. Efficacy and safety of XELOX combined with anlotinib and penpulimab vs XELOX as an adjuvant therapy for ctDNA-positive gastric and gastroesophageal junction adenocarcinoma: a protocol for a randomized, controlled, multicenter phase II clinical trial (EXPLORING study). Front Immunol. 2023 Oct 31;14:1232858. doi: 10.3389/fimmu.2023.1232858. eCollection 2023.
PubMed 38022553
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XELOX Combined With Anlotinib and Penpulimab vs XELOX as Adjuvant Therapy in ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma, a Randomized, Controlled, Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT05494060
- Acronym / sponsor ID
- EXPLORING / 2022-SR-342
- Conditions
- Carcinoma, Gastrointestinal Diseases, Stomach Cancer, Gastroesophageal-junction Cancer, Digestive System Diseases, Gastric Cancer
- Keywords
- Penpulimab, Anlotinib, Capecitabine, Oxaliplatin, ctDNA, adjuvant therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 16 Mar 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 9 Aug 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 is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma.
Detailed description
This is an open label, randomized, phase Ⅱ, multi-cohort study to treat subjects with ctDNA Positive Gastric and Esophagogastric Junction Adenocarcinoma. The patients will be randomized into two arms consist of Penpulimab + Anlotinib (3 weeks/cycle) + XELOX and XELOX at a ratio of 1:1. This study is conducted to assess safety and anti-tumor activity of the monoclonal antibody Penpulimab in combination with Anlotinib and standard chemotherapy as adjuvant treatment for ctDNA-positive Gastric, or Gastroesophageal Junction Carcinoma. The study includes a screening (up to 28 days), treatment (disease recurrence, unacceptable toxicity, or subject withdrawal of consent with a maximum 12 month), safety follow-up (up to 30 days following last study drug treatment), and survival follow-up phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Penpulimab + Anlotinib + XELOX； Active Comparator: XELOX
| Arm | Type | Receives |
|---|---|---|
| Penpulimab + Anlotinib + XELOX | Experimental | Drug: Anlotinib hydrochloride capsule, Drug: Penpulimab Injection, Drug: XELOXPenpulimab in combination with Anlotinib and XELOX (Capecitabine and Oxaliplatin) |
| XELOX | Active comparator | Drug: XELOXXELOX (Capecitabine and Oxaliplatin) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Subjects aged ≥18 and ≤75 years old, male or female.
- ECOG performance status score 0-1.
- Histologically or cytologically confirmed GC or GEJ carcinoma, had been treated with Radical resection (D2, R0 or R1) of gastric cancer.
- Pathological stage:III (8th AJCC TNM).
- Estimated lifetime is greater than 6 months.
Key exclusion criteria (19 listed)
- Participation in other drug clinical trials within four weeks.
- Multiple factors affecting oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction.
- History of bleeding, any bleeding event with a severity grade of 3 or higher per CTCAE 5.0 within 4 weeks before screening.
- Patients with known central nervous system metastasis or history of central nervous system metastasis prior to screening. For patients with clinically suspected central nervous system metastases, CT or MRI must be performed within 28 days before enrollment to rule out central nervous system metastases.
- Patients with hypertension and uncontrolled by antihypertensive drugs alone (systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg); Patients with a history of unstable angina pectoris; Patients newly diagnosed as angina pectoris within 3 months before screening or myocardial infarction events within 6 months before screening; Arrhythmias (including QTcF ≥ 450 ms in men, ≥ 470 ms in women requiring long-term use of antiarrhythmic drugs and New York Heart Association Class ≥ II cardiac insufficiency;There are many factors that affect oral drug absorption (such as inability to swallow, nausea and vomiting, upper gastrointestinal obstruction, abnormal physiological function, malabsorption syndrome, etc.), which may affect anlotinib hydrochloride absorbers.
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 |
|---|---|---|
| Anlotinib hydrochloride capsuleAnlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)； | Drug | Penpulimab + Anlotinib + XELOX |
| Penpulimab InjectionAlso: AK-105Penpulimab Injection 100mg per bottle, 200mg IV Day 1, cycled every 21 days | Drug | Penpulimab + Anlotinib + XELOX |
| XELOXAlso: Capecitabine and OxaliplatinCapecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w | Drug | Penpulimab + Anlotinib + XELOX, XELOX |
Primary outcome
Disease Free Survival (DFS)
Time frame: up to 2 years
From date of receiving therapy until date of disease recurrence or death (by any cause in the absence of recurrence).
2 secondary outcomes
Disease Free Survival (DFS) rate at 2 years
Time frame: 2 years
Disease Free Survival (DFS) rate at 3 years
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Derived from this study: PubMed 38022553Chen Y, Zhang J, Han G, Tang J, Guo F, Li W, Xie L, Xu H, Zhang X, Tian Y, Pan L, Shu Y, Ma L, Chen X. Efficacy and safety of XELOX combined with anlotinib and penpulimab vs XELOX as an adjuvant therapy for ctDNA-positive gastric and gastroesophageal junction adenocarcinoma: a protocol for a randomized, controlled, multicenter phase II clinical trial (EXPLORING study). Front Immunol. 2023 Oct 31;14:1232858. doi: 10.3389/fimmu.2023.1232858. eCollection 2023.
- Individual participant dataSharing planned: Undecided
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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.
Ext: Shu, PhD principal investigator
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Anlotinib hydrochloride capsule, Penpulimab Injection and XELOX in people with Carcinoma and Gastrointestinal Diseases, run by The First Affiliated Hospital with Nanjing Medical University at 1 site 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 19 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yongqian Shu, PhD (0086-025-68306428, shuyongqian@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Free Survival (DFS) (time frame: up to 2 years). 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 NCT05494060, 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 7 Nov 2023.