Trial Outcomes & Findings for Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma (NCT NCT04649476)
NCT ID: NCT04649476
Last Updated: 2025-01-10
Results Overview
Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Hematoxylin and eosin (H\&E)-stained slides of entire tumor and all sampled lymph nodes were scanned and assessed by two independent pathologists. The entire tumor bed and all sampled lymph nodes were examined histologically in patients who had pathological complete response (pCR), which was defined as the absence of viable tumor in all slides. MPR was defined as the presence of 10% or less viable residual tumor in the resected tumor specimens. Pathological partial response (pPR) was defined as presence of more than 10% and less than 50% viable residual tumor and pathological non-response (pNR) was defined as presence of more than 50% viable residual tumor in the resected tumor specimens. Pathologic response was defined as sum of pCR and MPR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
68 participants
Primary outcome timeframe
8 weeks.
Results posted on
2025-01-10
Participant Flow
Participant milestones
| Measure |
Neoadjuvant PD-1 Blockade Alone
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
34
|
|
Overall Study
COMPLETED
|
34
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant PD-1 Blockade in Resectable Oral Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Neoadjuvant PD-1 Blockade Alone
n=34 Participants
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
n=34 Participants
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
Total
n=68 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Continuous
|
52.0 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
49.5 years
STANDARD_DEVIATION 10.0 • n=7 Participants
|
50.7 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
34 participants
n=5 Participants
|
34 participants
n=7 Participants
|
68 participants
n=5 Participants
|
|
Tumor site
Oral tongue
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Tumor site
Gingiva
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Tumor site
Floor of mouth
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Tumor site
Buccal mucosa
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Smoking history
Current or former
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Smoking history
Never
|
10 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Alcohol use history
Current or former
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Alcohol use history
Never
|
19 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Clinical T-stage
T2 (Tumour more than 2 cm but not more than 4 cm in greatest dimension) better outcomes
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Clinical T-stage
T3 (Tumour more than 4 cm in greatest dimension)
|
19 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Clinical T-stage
T4a (Tumour invades through cortical bone, maxillary sinus) worse outcomes
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Clinical N-stage
N0 (No regional lymph node metastasis) better outcomes
|
23 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Clinical N-stage
N1 (Metastasis in a single ipsilateral lymph node, 3 cm or less in great est dimension)
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Clinical N-stage
N2 (Lymph node metastasis more than 3 cm but no more than 6 cm in greatest dimension) worse outcomes
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
PD-L1 combined positive score
<1 (Considered as negative PD-L1 expression) worse outcomes
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
PD-L1 combined positive score
1-19 (Considered as positive PD-L1 expression)
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
PD-L1 combined positive score
>=20 (Considered as positive PD-L1 expression) better outcomes
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks.Pathologic response of resected tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy. Hematoxylin and eosin (H\&E)-stained slides of entire tumor and all sampled lymph nodes were scanned and assessed by two independent pathologists. The entire tumor bed and all sampled lymph nodes were examined histologically in patients who had pathological complete response (pCR), which was defined as the absence of viable tumor in all slides. MPR was defined as the presence of 10% or less viable residual tumor in the resected tumor specimens. Pathological partial response (pPR) was defined as presence of more than 10% and less than 50% viable residual tumor and pathological non-response (pNR) was defined as presence of more than 50% viable residual tumor in the resected tumor specimens. Pathologic response was defined as sum of pCR and MPR.
Outcome measures
| Measure |
Neoadjuvant PD-1 Blockade Alone
n=34 Participants
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
n=34 Participants
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
|---|---|---|
|
Pathologic Response.
Number of participants who had no response
|
25 Participants
|
2 Participants
|
|
Pathologic Response.
Number of participants who had partial response
|
4 Participants
|
4 Participants
|
|
Pathologic Response.
Number of Participants Pathologic response (pCR+MPR)
|
5 Participants
|
26 Participants
|
|
Pathologic Response.
Non-evaluable
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 8 weeks.Radiographic response of tumors and lymph nodes to neoadjuvant PD-1 blockade alone or neoadjuvant PD-1 blockade plus TPF induction chemotherapy were evaluated by enhanced computed tomography examinations and defined by Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. Complete Response (CR) was defined as disappearance of all target lesions. Partial Response (PR) was defined as \>=30% decrease in the sum of the longest diameter of target lesions. Stable disease (SD) was defined as \<20% increase and \<30% decrease in the sum of the longest diameter of target lesions. Progressive disease (PD) was defined as \>=20% increase in the sum of the longest diameter of target lesions. Overall Response (OR) = CR + PR.
Outcome measures
| Measure |
Neoadjuvant PD-1 Blockade Alone
n=34 Participants
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
n=34 Participants
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
|---|---|---|
|
Radiographic Response.
CR (Complete response)
|
0 Participants
|
0 Participants
|
|
Radiographic Response.
PR (Partial response)
|
3 Participants
|
16 Participants
|
|
Radiographic Response.
SD (Stable disease)
|
20 Participants
|
14 Participants
|
|
Radiographic Response.
PD (Progressive disease)
|
11 Participants
|
1 Participants
|
|
Radiographic Response.
Non-evaluable
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 24 months.EFS is the time from the date of randomization to the date of first record of disease progression as defined by RECIST 1.1.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months.OS is the time from randomization to death due to any cause.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 24 months.Number of participants experiencing any sign, symptom, disease, or worsening of preexisting conditions temporally associated with the experimental interventions or irrespective of the experimental interventions.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 months.The level of circulating exosomal PD-L1 at serial time points pre- and on-treatment, as detected by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
Outcome data not reported
Adverse Events
Neoadjuvant PD-1 Blockade Alone
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
Serious events: 11 serious events
Other events: 34 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Neoadjuvant PD-1 Blockade Alone
n=34 participants at risk
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
n=34 participants at risk
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
|---|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
2.9%
1/34 • Number of events 1 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
29.4%
10/34 • Number of events 10 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
17.6%
6/34 • Number of events 6 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Cardiac disorders
Creatine kinase increased
|
2.9%
1/34 • Number of events 1 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Renal and urinary disorders
Creatinine increased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
2.9%
1/34 • Number of events 1 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
14.7%
5/34 • Number of events 5 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
Other adverse events
| Measure |
Neoadjuvant PD-1 Blockade Alone
n=34 participants at risk
The participants will receive 3 doses of neoadjuvant PD-1 blockade. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumab: The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
|
Neoadjuvant PD-1 Blockade Plus TPF Induction Chemotherapy
n=34 participants at risk
The participants will receive 3 doses of PD-1 blockade and 2 courses of TPF induction chemotherapy. Then the participants will take a radical surgery followed by radiotherapy or chemoradiotherapy if necessary.
Camrelizumanb plus TPF: The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Reactive cutaneous capillary endothelial proliferation, RCCEP
|
85.3%
29/34 • Number of events 29 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
70.6%
24/34 • Number of events 24 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
20.6%
7/34 • Number of events 7 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
73.5%
25/34 • Number of events 25 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Skin and subcutaneous tissue disorders
Mucositis oral
|
17.6%
6/34 • Number of events 6 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
23.5%
8/34 • Number of events 8 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Renal and urinary disorders
Creatinine increased
|
17.6%
6/34 • Number of events 6 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
44.1%
15/34 • Number of events 15 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Hepatobiliary disorders
GGT increased
|
11.8%
4/34 • Number of events 4 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
14.7%
5/34 • Number of events 5 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
29.4%
10/34 • Number of events 10 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
82.4%
28/34 • Number of events 28 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
14.7%
5/34 • Number of events 5 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
38.2%
13/34 • Number of events 13 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
8.8%
3/34 • Number of events 3 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Hepatobiliary disorders
Blood lactate dehydrogenase increased
|
5.9%
2/34 • Number of events 2 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
26.5%
9/34 • Number of events 9 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
14.7%
5/34 • Number of events 5 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Hepatobiliary disorders
ALT increased
|
11.8%
4/34 • Number of events 4 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
32.4%
11/34 • Number of events 11 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Hepatobiliary disorders
AST increased
|
5.9%
2/34 • Number of events 2 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
23.5%
8/34 • Number of events 8 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Gastrointestinal disorders
Diarrhea
|
2.9%
1/34 • Number of events 1 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
29.4%
10/34 • Number of events 10 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
|
Cardiac disorders
Creatine kinase increased
|
0.00%
0/34 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
29.4%
10/34 • Number of events 10 • The specific period of time over which adverse events were collected is initiated from the begining of neoadjuvant treatment and end up with the adjuvant radiotherapy after surgery, up to 4 months
|
Additional Information
Gang Chen, MD
Hospital of Stomatology, Wuhan university
Phone: +86 02787686215
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place