Second Line Treatment of Gastric CancerPhase 2NCT05669807
Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
A Phase 2 study testing Camrelizumab, Albumin-Bound Paclitaxel and Irinotecan in people with Second Line Treatment of Gastric Cancer, run by Zhejiang Cancer Hospital.
Trial summary
This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. Read more about this study
- Who is it for?
- Ages 15 to 75 years
- Conditions the study is for
- Second Line Treatment of Gastric Cancer
- What is being tested?
- Camrelizumab, Albumin-Bound Paclitaxel and Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- Dec 2022to Nov 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 15 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age: 18-75
- ECOG score: 0 or 1
- Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
- histologically proven adenocarcinoma
- Received chemotherapy based on platinum and fluorouracil within 12 months
- Patients not previously treated with paclitaxel or irinotecan
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- Liver function: total bilirubin, ALT and AST<1.5 × ULN (Normal Value upper limit)
- Renal function: Cr<1.5 × ULN and creatinine clearance ≥ 40 ml/min
- Echocardiography or radionuclide cardiac function test, LVEF ≥ 50%
- Expected survival ≥ 3 months
- Sign the informed consent form
Who cannot join
- Patients who have received irinotecan or paclitaxel chemotherapy in the past
- ECOG PS score:>2
- Advanced gastric cancer patients with extensive and severe peritoneal metastasis
- Patients with severe liver and kidney insufficiency or cardiac insufficiency
- HIV positive, active hepatitis B or C, active pulmonary tuberculosis
- Patients with active autoimmune diseases, including lupus erythematosus, rheumatoid arthritis, rheumatoid arthritis, etc
- Patients known to be allergic to any of the study drugs
- Pregnant or lactating female patients
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
This study is a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.
- Conditions
- Second Line Treatment of Gastric Cancer
- Being tested
- Camrelizumab, Albumin-Bound Paclitaxel, Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called Camrel
200mg d1, the first day, every 14 days as a cycle
Albumin-Bound PaclitaxelDrug
Also called ABP
100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle
IrinotecanDrug
Also called Iri
180 mg/m2, the first day, every 14 days as a cycle
| Study group | Role | What they receive |
|---|---|---|
| A: Camrelizumab+Albumin-bound paclitaxel | Experimental | Camrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days Receives: Drug: Camrelizumab; Drug: Albumin-Bound Paclitaxel |
| B: Camrelizumab+Irinotecan | Experimental | Camrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle Receives: Drug: Camrelizumab; Drug: Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate
CR+PR
Measured: up to 12 weeks
Secondary outcomes (4)
Overall Survival
Time from random start of treatment to death from any cause
Measured: From date of randomization until the date of date of death from any cause, assessed up to 24 months
Progression-free Survival
Time from random start of treatment to death or tumor progression due to any reason
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Treatment related adverse reactions
Evaluation according to CTC 4.0
Measured: 24 months
Quality of life assessment
according to EORTC C30
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2023
- Study startDec 2022 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Second Line Treatment of Gastric CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Zhu, Zhejiang Cancer Hospital
- Investigators
- Ji Zhu, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05669807
- Sponsor's protocol ID
- CARTOnG-2101
- Status last verified
- Dec 2022
- First submitted
- 28 Nov 2022
- Last updated
- 3 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Phase II Study of Camrelizumab Combined With Irinotecan or Albumin Paclitaxel for Second-line Treatment of Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05669807
- Acronym / sponsor ID
- CARTOnG-2101
- Conditions
- Second Line Treatment of Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- Dec 2022 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 3 Jan 2023 (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 a multicenter, open, and randomized clinical phase II exploratory study. The "pick the winner" study design is used to determine and select which chemotherapy drug (irinotecan vs. albumin plus paclitaxel) is more effective in the second-line treatment of advanced gastric cancer, and it is more hopeful to carry out the follow-up phase III study in the second-line treatment of advanced gastric cancer (karelizumab+chemotherapy vs. chemotherapy). The study plans to include 184 patients with advanced gastric cancer who have received first-line platinum+fluorouracil progression, randomly use albumin paclitaxel+carrelizumab or irinotecan+carrelizumab second-line therapy, and observe the objective effective rate (ORR), total survival time (OS), progression free survival time (PFS), treatment related adverse reactions, quality of life and other clinical indicators after receiving the above treatment, Then determine the second line scheme which is more advantageous.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A: Camrelizumab+Albumin-bound paclitaxel | Experimental | Drug: Camrelizumab, Drug: Albumin-Bound PaclitaxelCamrelizumab 200mg d1, one cycle every 14 days on the first day; albumin binding paclitaxel: 100 mg/m2, one cycle every 28 days on the first, eighth and fifteenth days |
| B: Camrelizumab+Irinotecan | Experimental | Drug: Camrelizumab, Drug: IrinotecanCamrelizumab 200mg d1, the first day, every 14 days as a cycle Irinotecan: 180 mg/m2, the first day, every 14 days as a cycle |
Who may qualify
- Ages
- 15 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age: 18-75
- ECOG score: 0 or 1
- Unresectable advanced or recurrent gastric cancer/gastroesophageal junction cancer
- histologically proven adenocarcinoma
- Received chemotherapy based on platinum and fluorouracil within 12 months
Key exclusion criteria (8 listed)
- Patients who have received irinotecan or paclitaxel chemotherapy in the past
- ECOG PS score:>2
- Advanced gastric cancer patients with extensive and severe peritoneal metastasis
- Patients with severe liver and kidney insufficiency or cardiac insufficiency
- HIV positive, active hepatitis B or C, active pulmonary tuberculosis
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 |
|---|---|---|
| CamrelizumabAlso: Camrel200mg d1, the first day, every 14 days as a cycle | Drug | A: Camrelizumab+Albumin-bound paclitaxel, B: Camrelizumab+Irinotecan |
| Albumin-Bound PaclitaxelAlso: ABP100 mg/m2, the 1st, 8th and 15th days, every 28 days as a cycle | Drug | A: Camrelizumab+Albumin-bound paclitaxel |
| IrinotecanAlso: Iri180 mg/m2, the first day, every 14 days as a cycle | Drug | B: Camrelizumab+Irinotecan |
Primary outcome
Objective Response Rate
Time frame: up to 12 weeks
CR+PR
4 secondary outcomes
Overall Survival
Time frame: From date of randomization until the date of date of death from any cause, assessed up to 24 months
Progression-free Survival
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Treatment related adverse reactions
Time frame: 24 months
Quality of life assessment
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2023.
- Individual participant dataSharing planned: No
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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.
Ji Zhu principal investigator
Zhejiang Cancer Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab, Albumin-Bound Paclitaxel and Irinotecan in people with Second Line Treatment of Gastric Cancer, run by Zhejiang Cancer Hospital.
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 11 inclusion and 8 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 3 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Ji Zhu (0571-88128142, leo.zhu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2023.