This study intends to explore the role of PD1/PDL1 antibody with selective combination of Sintilimab, IBI310 and Lenvatinib in organ preservation in non-metastatic dMMR/MSI-H gastric or colon cancers with mismatch repair deficiency or high microsatellite instability
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
non-specific, according to Drug Instructions
Sintilimab 200mg, ivgtt, q21d; IBI310 1mg/kg, ivgtt, q42d; Lenvatinib 8mg (starting from 4mg), po, qd
Radical surgery will be recommended per local treatment standards.
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGOrgan preservation rate
The rate of patients who achieved cCR or near-cCR and did not undergo surgery after completion of established therapy, assessed among all patients who completed established therapy.
Time frame: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, 12 weeks after Sintilimab, IBI310 and Lenvatinib, and 24 weeks after Sintilimab, IBI310 and Lenvatinib
Organ preservation rate after completion of PD1/PDL1 antibody monotherapy
The rate of patients who achieve cCR or near-cCR and do not undergo surgery after completion of PD1/PDL1 antibody monotherapy, assessed among all patients who completed PD1/PDL1 antibody monotherapy
Time frame: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated after completion of PD1/PDL1 antibody monotherapy, an average of 24 weeks
Organ preservation rate after completion of selective combination of Sintilimab, IBI310 and Lenvatinib
The rate of patients who achieved cCR or near-cCR and did not undergo surgery after completion of selective combination of Sintilimab, IBI310 and Lenvatinib, assessed among all patients who do not achieve cCR or near-cCR after PD1/PDL1 antibody monotherapy, and all patients who achieve cCR or near-cCR after PD1/PDL1 antibody monotherapy but have disease progression during follow-up
Time frame: The status of cCR or near-cCR and the possibility of organ preservation will be evaluated 12 weeks and 24 weeks after Sintilimab, IBI310 and Lenvatinib
Objective response rate of selective combination of Sintilimab, IBI310 and Lenvatinib
Objective response rate (defined as CR+PR) will be reported based on investigator's evaluation according to RECIST 1.1
Time frame: Baseline up to withdrawal of consent, progressive disease, unacceptable toxicity, or surgery (whichever occurs first), up to 8 years
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Disease control rate of selective combination of Sintilimab, IBI310 and Lenvatinib
Disease control rate (defined as CR+PR+SD) will be reported based on investigator's evaluation according to RECIST 1.1
Time frame: Baseline up to withdrawal of consent, progressive disease, unacceptable toxicity, or surgery (whichever occurs first), up to 8 years
3 year organ preservation rate
Rate of 3 year surgery-free survival
Time frame: From first dose of PD1/PDL1 antibody until the date of surgery, assessed up to 3 years
3 year disease free survival rate
Rate of 3 year disease free survival
Time frame: From first dose of PD1/PDL1 antibody until disease progression (local or distant), secondary tumor or death (whichever occurs first), assessed up to 3 years
3 year overall survival rate
Rate of 3 year overall survival
Time frame: From first dose of PD1/PDL1 antibody until death, assessed up to 3 years
5 year overall survival rate
Rate of 5 year overall survival
Time frame: From first dose of PD1/PDL1 antibody until death, assessed up to 5 years
3 year local recurrence free survival rate
Rate of 3 year local recurrence free survival
Time frame: From first dose of PD1/PDL1 antibody until first local failure or death (whichever occurs first), assessed up to 3 years
3 year distant metastasis free survival rate
Rate of 3 year distant metastasis free survival
Time frame: From first dose of PD1/PDL1 antibody until distant metastasis or death (whichever occurs first), assessed up to 3 years
3 year surgery free survival rate
Rate of 3 year surgery free survival
Time frame: From first dose of PD1/PDL1 antibody until radical surgery or death (whichever occurs first), assessed up to 3 years
Treatment-related adverse event of combination of Sintilimab, IBI310 and Lenvatinib
A treatment-related adverse event (TRAE) is defined as any adverse event not present prior to the initiation of drug treatment or any adverse event already present that worsens in intensity or frequency following exposure to the drug treatment. TRAEs were graded using National Cancer Institute (NCI)-CTCAE version 5.0.
Time frame: From first dose of Sintilimab, IBI310 and Lenvatinib to 30 days after last dose of treatment.
Quality of life of combination of Sintilimab, IBI310 and Lenvatinib for gastric cancer patients
Quality of life will be evaluated using EORTC QLQ-C30 and QLQ-STO22.
Time frame: From first dose of PD1/PDL1 antibody until death, assessed up to 8 years
Quality of life of combination of Sintilimab, IBI310 and Lenvatinib for colon cancer patients
Quality of life will be evaluated using EORTC QLQ-C30 and EORTC QLQ-CR29.
Time frame: From first dose of PD1/PDL1 antibody until death, assessed up to 8 years
Rate of complications
Rate of complications in perioperative period
Time frame: From 7 days before surgery to 12 days after surgey
Rate of mortality
Rate of mortality in perioperative period
Time frame: From 7 days before surgery to 12 days after surgey