Trial Outcomes & Findings for Neoadjuvant Therapy for Locally Advanced Colon Cancer (NCT NCT04625803)

NCT ID: NCT04625803

Last Updated: 2025-06-17

Results Overview

the percentage of tumor regression rate (2-4) in pMMR patients

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 64 participants
• Primary outcome timeframe: 2 years
• Results posted on: 2025-06-17

Participant Flow

Participant milestones

Measure	Chemotherapy, PD-1 Inhibitor and Apatinib Participants received 5 preoperative cycles of PD-1 inhibitor and chemotherapy (mFOLFOX6), 2 months of apatinib, followed by surgery. Apatinib,PD-1 inhibitor and chemotherapy needed to be stopped for 4-6 months before operation. 1 month after surgery, 7 cycles of mFOLFOX6 combined with PD-1 monoclonal antibody were performed as adjuvant therapy. Camrelizumab , apatinib and chemotherapy: Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle Apatinib 250mg oral administration once a day, for two months mFOLFOX6 oxaliplatin 85 mg/m\^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate.
Overall Study STARTED	64
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	52

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neoadjuvant Therapy for Locally Advanced Colon Cancer

Baseline characteristics by cohort

Measure	Chemotherapy, PD-1 Inhibitor and Apatinib n=12 Participants From January 2021 to September 2022, 12 patients were enrolled. Most (10 \[83.3%\] of 12) patients were female. There were 10 patients (83.3%) with right-sided colon cancer. 7(58.3%) had cT4 stage tumors, and all patients had positive lymph nodes on baseline radiographic assessment. 10 (83.3%) completed the planned cycles of neoadjuvant therapy. 1 patient received 3 cycles of neoadjuvant therapy as a serious adverse event and 1 patient received 2 cycles of neoadjuvant therapy as tumor perforation . Of the 12 patients, 11 underwent surgery, of whom R0 resection was performed and 1 refused
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
ECOG performance status 0	8 Participants n=5 Participants
ECOG performance status 1	3 Participants n=5 Participants
ECOG performance status 2	1 Participants n=5 Participants
Clinical T stage cT3	5 Participants n=5 Participants
Clinical T stage cT4a	5 Participants n=5 Participants
Clinical T stage cT4b	2 Participants n=5 Participants
Clinical N stage cN0	0 Participants n=5 Participants
Clinical N stage cN1	5 Participants n=5 Participants
Clinical N stage cN2	7 Participants n=5 Participants
MMR status dMMR	4 Participants n=5 Participants
MMR status pMMR	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

the percentage of tumor regression rate (2-4) in pMMR patients

Outcome measures

Measure	Tumor Regression Grade Rate of pMMR Patients n=8 Participants the percentage of tumor regression rate (2-4) in pMMR patients
Tumor Regression Rate of MSS/pMMR Patients	7 Participants

SECONDARY outcome

Timeframe: 2 years

Percentage of patients with pathological complete response

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

R0 resection accounted for the percentage of all surgical patients=100%

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Disease-free survival (DFS) is defined as the time from operation to recurrence of tumor or death. We will evaluate 2 year DFS is 100%

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Refers to the time of death from enrollment to any cause

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

The period from the beginning of neoadjuvant therapy to the occurrence of any of the following events, whichever occurs first: tumor progression as assessed by RECIST 1.1; Tumor recurrence, including local recurrence or distant metastasis; Death from any cause; EFS=100%

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

The complication rate of all patients during the period around the time of a surgical operation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

the ratio between deaths and all patients in the study during treatment

Outcome measures

Measure	Tumor Regression Grade Rate of pMMR Patients n=12 Participants the percentage of tumor regression rate (2-4) in pMMR patients
Mortality Rate	0 Participants

Adverse Events

Neutropenia

Serious events: 10 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	Neutropenia n=12 participants at risk the most common adverse events were neutropenia (83.3%)
Blood and lymphatic system disorders neutropenia	83.3% 10/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Blood and lymphatic system disorders decreased white blood cell count	33.3% 4/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Blood and lymphatic system disorders thrombocytopenia	16.7% 2/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Blood and lymphatic system disorders hypertension	16.7% 2/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Blood and lymphatic system disorders ALT increased	16.7% 2/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.

Other adverse events

Measure	Neutropenia n=12 participants at risk the most common adverse events were neutropenia (83.3%)
Cardiac disorders Hypertension	16.7% 2/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Cardiac disorders RCCEP	66.7% 8/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.
Gastrointestinal disorders Vomiting	33.3% 4/12 • 2 year Grade ≥3 adverse events occurred in 83.3% of patients, including neutropenia, decreased white blood cell count, thrombocytopenia, hypertension and alanine aminotransferase (ALT) increase.

Additional Information

Weijia Fang

The First Affiliated Hospital, Zhejiang University School of Medicine

Phone: +86 87235147

Email: weijiafang@zju.edu.cn

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place