Extensive Stage Small Cell Lung CancerPhase 1NCT05001412
Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of ES-SCLC
A Phase 1 study testing Camrelizumab; apatinib; carboplatin; etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Zhou Chengzhi at 1 site in China.
Trial summary
The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Extensive Stage Small Cell Lung Cancer
- What is being tested?
- Camrelizumab; apatinib; carboplatin; etoposide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 27 Jan 2021to 25 Jan 2024
- Phase
- Phase 1
- 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
- 1. Extensive stage small cell lung cancer proved by pathology.
- 2. Extensive small cell lung cancer does not receive systematic treatment.
- 3. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
- 4. patients have measurable lesions according to RECIST version 1.1.
- 5. Male or female who is 18 to 75 years old.
- 6. ECOG PS 0 or 1.
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- 7. Life expectancy is more than12 weeks.
- 8. Appropriate organ system function.
- 9. hyroid-stimulating hormone is ULN or less (If T3 and T4 is normal, he still meets the Inclusion Criteria even the abnormal TSH. )
- 10. Take proper contraceptive measures.
- 11. Subjects voluntarily participate in this study and sign the informed consent.
Who cannot join
- 1. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
- 2. Cancer meningitis.
- 3. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- 4. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
- 5. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
- 6. Patients with spinal cord compression who were not cured or relieved by surgery and/or radiotherapy, or who were diagnosed with spinal cord compression after treatment and without clinical evidence of stable disease ≥1 week before enrollment;
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- 7. Patients with hypertension who cannot be well controlled by oral antihypertensive therapy, suffer from myocardial ischemia or myocardial infarction of grade I or above, arrhythmias of grade I or above , or cardiac insufficiency;
- 8. Subjects had signs of bleeding, hemoptysis, or a history of unhealed wounds, ulcers, fractures within 2 months prior to initial administration.
- 9. The adverse events caused by previous treatment did not completely recover.
- 10. Patients with major surgery or obvious traumatic injury within 28 days before enrollment;
- 11. Occurred arterial or venous thromboembolism events within 6 months.
- 12. People with a history of drug abuse or mental disorders.
- 13. Suffering from a serious and/or uncontrollable disease;
- 14. Vaccination or attenuated vaccine received within 4 weeks.
- 15. Severe allergies that require treatment with other monoclonal antibody drugs;
- 16. Active autoimmune disease requiring systemic treatment within 2 years prior to the first administration;
- 17. Immunosuppressive therapy with systemic or absorbable local hormones and continued for 2 weeks after the first dose;
- 18. Participate in other anticancer drug clinical trials within 4 weeks;
- 19. In the investigator's judgment, there are other factors that may have led to the termination of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
Ming Liu, MD, 18688380929, mingliu128@hotmail.com
About this study
Official title: Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer
The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.
Read the detailed description
Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Being tested
- Camrelizumab; apatinib; carboplatin; etoposide
- Keywords
- Camrelizumab; apatinib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab; apatinib; carboplatin; etoposideDrug
2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib
| Study group | Role | What they receive |
|---|---|---|
| Cohort one | Experimental | Extensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less. Receives: Drug: Camrelizumab; apatinib; carboplatin; etoposide |
| Cohort two | Experimental | Extensive SCLC patients who are central type or tumor vascular invasion grade two to three. Receives: Drug: Camrelizumab; apatinib; carboplatin; etoposide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Dose-limiting toxicities
Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)
Measured: Followed up every 3 weeks.
Secondary outcomes (2)
PFS
Progression Free Survival
Measured: Imageological diagnosis every 6 weeks
12 months OS
12 months overall survival
Measured: Followed up by telephone every 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start27 Jan 2021
- Primary completion25 Jan 2023 (estimated)
- Study completion25 Jan 2024 (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 Extensive Stage Small Cell Lung CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- We divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vessels
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhou Chengzhi
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor-investigator, Zhou Chengzhi, Guangzhou Institute of Respiratory Disease
- Investigators
- Chengzhi Zhou, MD, Study director, The First Affiliated Hospital of Guangzhou Medical UniversityXin Chen, MD, Principal investigator, Zhujiang Hospital affiliated to Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001412
- Sponsor's protocol ID
- CROC-2021
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan.
Publications
Liu M, Qiu G, Guan W, Xie X, Lin X, Xie Z, Zhang J, Qin Y, Du H, Chen X, Deng Y, Li S, Zhong N, Zhou C. Induction chemotherapy followed by camrelizumab plus apatinib and chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: a multicenter, single-arm trial. Signal Transduct Target Ther. 2025 Feb 18;10(1):65. doi: 10.1038/s41392-025-02153-7.
PubMed 39962074
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Chemotherapy Combined With Camrelizumab and Apatinib in First-line Treatment of Extensive Stage Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05001412
- Acronym / sponsor ID
- CROC-2021
- Conditions
- Extensive Stage Small Cell Lung Cancer
- Keywords
- Camrelizumab; apatinib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Zhou ChengzhiUniversity, hospital or other
- Collaborators
- Jiangsu Hengrui Pharmaceutical Co., Ltd.
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- 25 Jan 2023 (estimated)
- Study completion
- 25 Jan 2024 (estimated)
- First posted
- 12 Aug 2021 (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.
The efficacy of PD-1/PD-L1 combined with chemotherapy in the treatment of extensive small-cell lung cancer is still unsatisfactory. PD-1/PD-L1 combined with chemotherapy and anti-angiogenic drugs may achieve better efficacy.
Detailed description
Camrelizumab is a humanized PD-1 monoclonal antibody. Camrelizumab combined with the antiangiogenic drug apatinib has achieved good efficacy in extensive small-cell lung cancer. Median OS is 8.4 months. In our study, subjects with extensive stage small cell lung cancers receive 2 cycles of chemotherapy followed by carrizumab combined with apatinib and chemotherapy. we hope to achieve a better outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- We divide them into two cohorts based on the extent of tumor invasion to the mediastinum or hilar large vessels
| Arm | Type | Receives |
|---|---|---|
| Cohort one | Experimental | Drug: Camrelizumab; apatinib; carboplatin; etoposideExtensive SCLC patients who are Peripheral type or tumor vascular invasion grade one or less. |
| Cohort two | Experimental | Drug: Camrelizumab; apatinib; carboplatin; etoposideExtensive SCLC patients who are central type or tumor vascular invasion grade two to three. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 1. Extensive stage small cell lung cancer proved by pathology.
- 2. Extensive small cell lung cancer does not receive systematic treatment.
- 3. limited SCLC patients have received radiotherapy and chemotherapy for more than 6 months.
- 4. patients have measurable lesions according to RECIST version 1.1.
- 5. Male or female who is 18 to 75 years old.
Key exclusion criteria (19 listed)
- 1. Previous treatment with apatinib, anti-programmed cell death (PD-1), anti-PD-1, or other PD-1/ PD-L1 immunotherapy.
- 2. Cancer meningitis.
- 3. patients had been diagnosed and/or treated for other malignancies within 5 years prior to enrollment, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix.
- 4. There are many factors affecting oral medication, such as inability to swallow, post-gastrointestinal resection, chronic diarrhea, intestinal obstruction, etc..
- 5. Uncontrollable pleural effusion, pericardial effusion or ascites, requiring repeated drainage.
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 |
|---|---|---|
| Camrelizumab; apatinib; carboplatin; etoposide2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib | Drug | Cohort one, Cohort two |
Primary outcome
Safety: Dose-limiting toxicities
Time frame: Followed up every 3 weeks.
Any level 4 or greater hematologic toxicity and any level 3 or greater non-hematologic toxicity (accroding to CTC AE 5.0)
2 secondary outcomes
PFS
Time frame: Imageological diagnosis every 6 weeks
12 months OS
Time frame: Followed up by telephone every 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Derived from this study: PubMed 39962074Liu M, Qiu G, Guan W, Xie X, Lin X, Xie Z, Zhang J, Qin Y, Du H, Chen X, Deng Y, Li S, Zhong N, Zhou C. Induction chemotherapy followed by camrelizumab plus apatinib and chemotherapy as first-line treatment for extensive-stage small-cell lung cancer: a multicenter, single-arm trial. Signal Transduct Target Ther. 2025 Feb 18;10(1):65. doi: 10.1038/s41392-025-02153-7.
- Individual participant dataSharing planned: No. No plan.
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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.
Chengzhi Zhou, MD study director
The First Affiliated Hospital of Guangzhou Medical University
Xin Chen, MD principal investigator
Zhujiang Hospital affiliated to Southern 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 1 study testing Camrelizumab; apatinib; carboplatin; etoposide in people with Extensive Stage Small Cell Lung Cancer, run by Zhou Chengzhi 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 11 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: status not confirmed, as of the sponsor's last update on 12 Aug 2021. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Chengzhi Zhou, MD (13560351186, doctorzcz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Dose-limiting toxicities (time frame: Followed up every 3 weeks.). 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 NCT05001412, 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 12 Aug 2021.