Oligometastatic Gastrointestinal CancerPhase 1NCT04625894

The Combination of Immunotherapy and Stereotactic Ablative Radiotherapy in Oligometastatic Gastrointestinal Cancer

A Phase 1 study testing Stereotactic Ablative Radiotherapy (SABR) and Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle in people with Oligometastatic Gastrointestinal Cancer, run by Fudan University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This is a single-center, open-label, single-arm phase I clinical study to exploratory observe and evaluate the efficacy and safety of anti-PD-1 antibody (Camrelizumab for Injection) combined with multisite stereotactic ablative radiotherapy (SABR) in patients with oligometastatic gastrointestinal cancer. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Oligometastatic Gastrointestinal Cancer
What is being tested?: Stereotactic Ablative Radiotherapy (SABR) and Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteChina
Study dates: Dec 2020to Jun 2023
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Aged 18-70 years old, regardless of gender;
Fully informed and willing to provide written informed consent for the trial;
ECOG performance status 0-1;
Expected survival time ≥ 6 months;
Has gastric carcinoma /colorectal carcinoma / hepatocellular carcinoma, confirmed by histopathology (or pathology consultation in our hospital) and measurable oligometastatic lesions on imaging (RECIST version 1.1); pathological diagnosis confirmation of oligometastatic lesions using biopsy tissue samples (e.g. obtained by hollow core needle, biopsy, excision, etc.) is recommended but not required;
Has undergone curative treatment on the primary lesion at least three months ago, without local progression;

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Has received standard treatment prior to enrolment, except for any type of immunotherapy;
Has no more than three metastatic lesions detected on imaging in single organ (e.g. lung, liver, brain, bone, etc.), and the total number of metastases is no more than five;
Multiple sites of lesions can be safely treated by SABR; and the maximum diameter of each lesion for irradiation is no more than 5cm.
Contraindicated for surgery or the participant refuses to receive surgery.
Has adequate organ function to tolerate the regimen:
Bone marrow function: neutrophils ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, hemoglobin ≥ 90 g/L;
Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal; AST and ALT ≤ 2.5 times the upper limit of normal or the presence of liver metastasis ≤ 5 times the upper limit of normal; total bilirubin ≤ 1.5 times the upper limit of normal, or patients with Gilbert's syndrome ≤ 2.5 times the upper limit of normal;
Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
Non-lactating patients.

Who cannot join

Pregnant or lactating women
Serious medical comorbidities precluding radiotherapy
Prior radiotherapy to a site requiring treatment
Malignant pleural effusion
Inability to treat all sites of active disease
Has clinical or radiologic evidence of spinal cord compression or tumor within 3mm of spinal cord on MRI.

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Dominant brain metastasis requiring surgical decompression
Has prior treatment with cancer immunotherapy including, but not limited to immune checkpoint inhibitors.
Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy at a dose of >10 mg Prednisone daily or equivalent at time of trial treatment.
Has a known history of active Bacillus Tuberculosis
Has active autoimmune disease that has required systemic treatment in the past 2 years
Hypersensitivity to PD-1 inhibitor or any of its excipients.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study day 1 or who has not recovered from adverse events due to a previously administered agent.

Trial locations and contacts

1 site in 1 country.

Zhen Zhang, MD, PhD contact

18801735029

zhen_zhang@fudan.edu.cn

China1 site

Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase I Clinical Trial of Multisite Stereotactic Ablative Radiotherapy (SABR) Combined With Camrelizumab in Patients With Oligometastatic Gastrointestinal Cancer

According to the origin site of metastases, this study will consist of three subgroups, including gastric carcinoma group, colorectal carcinoma group and hepatocellular carcinoma group. For each of the subgroup, seven eligible patients with oligometastatic cancer originating from stomach, colon and liver, respectively will be recruited. All patients will receive multisite SABR followed by immunotherapy of Camrelizumab within one week from completion. Camrelizumab will be administered at a fixed dose of 200 mg intravenously (iv) on D1 in a 14-day cycle. The treatment will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Tumor tissue samples, sections, paraffin blocks or biopsy blocks, and biomarkers, including but not limited to PD-L1 expression level and the proportion of positive cells, TMB level and MMR status, will be collected from subjects.

Conditions: Oligometastatic Gastrointestinal Cancer
Being tested: Stereotactic Ablative Radiotherapy (SABR), Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stereotactic Ablative Radiotherapy (SABR)Radiation
To irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy). Sequence of irradiation for multiple metastases will be at the discretion of the investigators based on their experience.
Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycleDrug
Administration of Carrelizumab will be started within one week upon SABR completion, and will be continued for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Study groups in NCT04625894
Study group	Role	What they receive
Treatment Arm	Experimental	Patients with oligometastatic gastrointestinal cancer will receive multisite SABR, followed by Camrelizumab within one week from completion of radiation. Camrelizumab for injection at 200 mg, d1, q2w, 14-day cycle will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal. Receives: Radiation: Stereotactic Ablative Radiotherapy (SABR); Drug: Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

Dose-limiting toxicities (DLT)
Defined as treatment-related Grade 3 or higher toxicities (excluding asymptomatic biochemical abnormalities) within 3 months, starting from the first day of radiotherapy. Toxicities will be assessed and graded according to NCI-CTCAE v5.0.
Measured: Up to 2 years

Secondary outcomes (5)

Adverse events (AEs)
Assessed according to NCI-CTCAE v5.0., and summarized by type and severity in tabular format to examine their frequency, organ systems affected, severity, and relationship to study treatment.
Measured: Up to 2 years
Local control (LC)
Defined as stable disease, partial response, or complete response based on serial imaging with CT scan. Recurrence will be defined as a suspicious mass at the site of SABR treated lesion, progressing in size on 2 consecutive computed tomography scans at a minimum interval of 1 month, combined with a positive FDG-PET defined by a SUV max ≥ 5, or a biopsy-proven confirmation.
Measured: Up to 2 years
Progression-free survival (PFS)
Regional or distant disease progression according to RECIST v1.1 or death due to any cause
Measured: Up to 2 years
Overall survival (OS)
A subject will be classified as either alive or dead due to any cause. The time to event will be calculated as the time from Day 1 until date of death. Day 1 is the date of 1st treatment with SABR.
Measured: Up to 2 years
Quality of life assessment
Assessed with the Functional Assessment of Cancer Therapy: General (FACT-G)
Measured: 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.

Dec 2020Jun 2023

First posted12 Nov 2020
Study startDec 2020 (estimated)
Primary completionDec 2022 (estimated)
Study completionJun 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Oligometastatic Gastrointestinal CancerStudies of the same condition, open and under way.
More trials run by Fudan 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 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04625894
Sponsor's protocol ID: MA-CRC-I-002
Status last verified: Nov 2020
First submitted: 6 Nov 2020
Last updated: 12 Nov 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

Zhen Zhang, MD, PhD

18801735029

zhen_zhang@fudan.edu.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
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Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
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Not yet recruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer
Esophageal Cancer
Not yet recruitingPhase 2
SBRT Combined With Iparomlimab and Tuvonralimab (QL1706) and Bevacizumab for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
RecruitingPhase 2
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Gastric Adenocarcinoma, Oligometastasis

All Oligometastatic Gastrointestinal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial of Multisite Stereotactic Ablative Radiotherapy (SABR) Combined With Camrelizumab in Patients With Oligometastatic Gastrointestinal Cancer
ClinicalTrials.gov ID: NCT04625894
Acronym / sponsor ID: MA-CRC-I-002
Conditions: Oligometastatic Gastrointestinal Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 21 participants (estimated)
Lead sponsor: Fudan UniversityUniversity, hospital or other
Study start: Dec 2020 (estimated)
Primary completion: Dec 2022 (estimated)
Study completion: Jun 2023 (estimated)
First posted: 12 Nov 2020 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Treatment Arm	Experimental	Radiation: Stereotactic Ablative Radiotherapy (SABR), Drug: Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cyclePatients with oligometastatic gastrointestinal cancer will receive multisite SABR, followed by Camrelizumab within one week from completion of radiation. Camrelizumab for injection at 200 mg, d1, q2w, 14-day cycle will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

Aged 18-70 years old, regardless of gender;
Fully informed and willing to provide written informed consent for the trial;
ECOG performance status 0-1;
Expected survival time ≥ 6 months;
Has gastric carcinoma /colorectal carcinoma / hepatocellular carcinoma, confirmed by histopathology (or pathology consultation in our hospital) and measurable oligometastatic lesions on imaging (RECIST version 1.1); pathological diagnosis confirmation of oligometastatic lesions using biopsy tissue samples (e.g. obtained by hollow core needle, biopsy, excision, etc.) is recommended but not required;

Key exclusion criteria (13 listed)

Pregnant or lactating women
Serious medical comorbidities precluding radiotherapy
Prior radiotherapy to a site requiring treatment
Malignant pleural effusion
Inability to treat all sites of active disease

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
Stereotactic Ablative Radiotherapy (SABR)To irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy). Sequence of irradiation for multiple metastases will be at the discretion of the investigators based on their experience.	Radiation	Treatment Arm
Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycleAdministration of Carrelizumab will be started within one week upon SABR completion, and will be continued for up to two years until disease progression, unacceptable toxicity or patient withdrawal.	Drug	Treatment Arm

Primary outcome

Dose-limiting toxicities (DLT)
Time frame: Up to 2 years
Defined as treatment-related Grade 3 or higher toxicities (excluding asymptomatic biochemical abnormalities) within 3 months, starting from the first day of radiotherapy. Toxicities will be assessed and graded according to NCI-CTCAE v5.0.

5 secondary outcomes

Adverse events (AEs)
Time frame: Up to 2 years
Local control (LC)
Time frame: Up to 2 years
Progression-free survival (PFS)
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Quality of life assessment
Time frame: 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 12 Nov 2020.

Related trials for Oligometastatic Gastrointestinal Cancer

RecruitingPhase 2
Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
Metastatic Colorectal Adenocarcinoma, Stage IV Colorectal Cancer AJCC v8
Not yet recruitingPhase 2
Serplulimab, DOS and Lenvatinib Combine With PIPAC in the Oligometastatic Peritoneal Metastasis of Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric/Gastroesophageal Junction Adenocarcinoma, Oligometastatic Peritoneal Metastasis
Not yet recruitingPhase 2
Stereotactic Body Radiation Therapy (SBRT) and Immunotherapy for Oligometastatic Esophageal Cancer
Esophageal Cancer
Not yet recruitingPhase 2
SBRT Combined With Iparomlimab and Tuvonralimab (QL1706) and Bevacizumab for Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC)
RecruitingPhase 2
Chemotherapy With or Without Radiation or Surgery in Treating Participants With Oligometastatic Esophageal or Gastric Cancer
Gastric Adenocarcinoma, Oligometastasis

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.

Zhen Zhang, MD, PhD contact

18801735029

zhen_zhang@fudan.edu.cn

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 13 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 Nov 2020. 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 Zhen Zhang, MD, PhD (18801735029, zhen_zhang@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (DLT) (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 NCT04625894.

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 Nov 2020.